[Solved] GLR STUDY

Assignment Prompt & Instructions

– ## GRLASSIGNMENTNUMBER2.docx

– ## GRLR-HomeworkAssignment2-supportingdocument-StridePharmaceuticalWL.pdf

– GRLR-HomeworkAssignment2-supportingdocument-2022FDAOutofSpecificationguidance.pdf

**## GRLASSIGNMENTNUMBER2.docx**

Version 10

**Homework Assignment 2**

Pathway for Patient Health

Global Regulatory and Legal Requirements of Quality

| |
| — |
| **Complete this assignment by typing your answers into this Word document** |

First Name:

Last Name:

Email address:

· Save this file as: First Name Last Name GRLR Project 2 (e.g. Marla Phillips GRLR Project 2.doc)

· Submit this assignment in Canvas

· Assignment due dates are as listed in the syllabus.

· Generative AI use is not allowed on this assignment.

| |
| — |
| **This assignment must be submitted by the due date that was provided to you by 11:59pm (EST)** |

**Review the Warning Letter issued to Strides Pharmaceutical by the FDA on July 1, 2019.**

**Resources** you will need for this Assignment:

· As the warning letter under review in this assignment may not be available on the active
[www.FDA.gov](http://www.fda.gov/) website, a copy has been provided in your class materials.

· The 2022 FDA Out-of-Specification Guidance.
[https://www.fda.gov/media/158416/download](https://www.fda.gov/media/158416/download)

**Questions:**

1. Explain why the “Quality System” was determined to be inadequate by the FDA. Provide evidence from the Warning Letter to support your response. Identify 3 sections of 21CFR211 (Title 21 of the Code of Federal Regulation, Part 211) that you feel were violated, and explain why.

(
**Hint:** See the assignment rubric below to ensure that you are providing a complete answer.)

2. After reviewing the 2022 FDA Guidance on handling out of specification test results (only need to read sections I – IV.B.1), what should Strides Pharmaceuticals have done to investigate their failing results? Provide a brief explanation of the steps they should have taken.

(
**Hint:** See the assignment rubric below to ensure that you are providing a complete answer.)

3. Practice looking up warning letters on the FDA.gov website.

a. Find the FDA searchable Warning Letter database page.

b. Provide the following information for the most recent Warning letter issued by the Center of Drug Evaluation and Research (CDER).

i. Link to warning letter:

ii. Company name:

iii. List the violation(s) cited and the referenced regulations (if there are more than two violations sited, just provide information on two):

(Note: This will look something like this:

_Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a))._

-or, for another example:

_Your product is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a)._)

| | |
| — | — |
| **Grading Comments for Question 1** | **Score for Question 1**<br>**(Possible 4)** |
| | |

| | |
| — | — |
| **Grading Comments for Question 2** | **Score for Question 2**<br>**(Possible 4)** |
| | |

| | |
| — | — |
| **Grading Comments for Question 3** | **Score for Question 2**<br>**(Possible 2)** |
| | |

**Rubric:**

| | | | | |
| — | — | — | — | — |
| | **Does not meet requirements** | **Some requirements met** | **Good** | **Excellent** |
| **Questions 1** | No engagement/effort with this question. (0)<br>Use of AI (0) | The student identified some minimal examples of quality system violations, but did not provide CFR references or explanation. (1) | The student identified examples of quality system violations, provided CFR references, but did not explain how the CFR sections were violated. (2-3) | The student identified examples of quality system violations, provided CFR references, and explained how the CFR sections were violated. (4) |
| **Question 2** | No engagement/effort with this question. (0)<br>Use of AI (0) | The student attempted to identify what Stride should have done to investigate the failing results, but the explanation was inadequate, and the student did not describe the steps. (1) | The student identified what Stride should have done to investigate the failing results, but did not describe the steps. (2-3) | The student identified what Stride should have done to investigate the failing results, and described the steps (4) |
| **Question 3** | No engagement/effort with this question. (0)<br>Use of AI (0) | The student provides a reference to a warning letter from an FDA Center other than CDER (0.5) | The student identifies and references a CDER issued warning letter but does not accurately identify the violations and CFR references. (1-1.5) | The student identifies and references a CDER issued warning letter and correctly provides the requested information. (2) |

Marla A. Phillips, Ph.D. | CEO and President | Pathway for Patient Health

Marla.Phillips@Pathway4PH.org | 513-238-4338 | www.Pathway4PH.org

## image1.png

**## GRLR-HomeworkAssignment2-supportingdocument-StridePharmaceuticalWL.pdf**

1/12/2020 Strides Pharma Science Limited – 576722 – 07/01/2019 | FDA

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/strides-pharma-science-limited-576722-07012019 1/5

WARNING LETTER

Strides Pharma Science Limited
MARCS-CMS 576722 — JULY 01, 2019

Delivery Method:

UPS

Product:

Drugs

UPS Warning Letter 320-19-28

Return Receipt Requested

July 01, 2019

Mr. Arun Kumar

Chief Executive Officer/Managing Director

Recipient:

Mr. Arun Kumar

Chief Executive O�cer/Managing Director

Strides Pharma Science Limited

Strides House, Bilekahalli
Bannerghatta Road
Bangalore 560076
India

Issuing O�ce:

Center for Drug Evaluation and Research

10903 New Hampshire Avenue
Silver Spring, MD 20993
United States

1/12/2020 Strides Pharma Science Limited – 576722 – 07/01/2019 | FDA

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/strides-pharma-science-limited-576722-07012019 2/5

Strides Pharma Science Limited

Strides House, Bilekahalli

Bannerghatta Road

Bangalore 560076

India

Dear Mr. Kumar:

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Strides Pharma Science
Limited at Unit-II, R. S. No.: 32, 33 & 34 PIMS Road Periyakalapet, Puducherry, from January 28 to February 5, 2019.

This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for
finished pharmaceuticals. See 21 CFR, parts 210 and 211.

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to
CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

We reviewed your February 26, 2019, response in detail and acknowledge receipt of your subsequent correspondence.

During our inspection, our investigators observed specific violations including, but not limited to, the following.

1. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve
or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling,
and drug products (21 CFR 211.22(a)).

Your quality unit (QU) lacks appropriate responsibility and control over your drug manufacturing operations.
During the inspection, our investigator observed discarded CGMP documents and evidence of uncontrolled shredding of
documents. For example, multiple bags of uncontrolled CGMP documents with color coding indicating they were from
drug production, quality, and laboratory operations were awaiting shredding. Our investigator also found a blue binder
containing CGMP records, including batch records for U.S. drug products, discarded with other records in a 55-gallon
drum in your scrap yard. CGMP documents in the binder were dated as recently as January 21, 2019: seven days before
our inspection. Your QU did not review or check these documents prior to disposal.
Your QU is responsible for the oversight of your drug manufacturing operations, including the review and approval of
documents and document controls, to ensure a complete contemporaneous record of each batch of drug product
manufactured. That record is retained for CGMP purposes including annual review. In addition, your QU is responsible
for ensuring your production areas are adequately monitored and that employees understand your firm’s procedures and
their assigned tasks.
The uncontrolled destruction of CGMP records, and your lack of adequate documentation practices, raise questions about
the effectiveness of your QU and the integrity and accuracy of your CGMP records.
In your response you state the binder of CGMP documents in your scrap yard was “inadvertently come [sic] to scrap
yard” and that you were investigating the issue. You also committed to using bound log books and restricting printing to
reduce uncontrolled documents. In addition, you committed to strengthen your training program to include instructor-led
classes geared towards good documentation practices.

1/12/2020 Strides Pharma Science Limited – 576722 – 07/01/2019 | FDA

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/strides-pharma-science-limited-576722-07012019 3/5

Your response is inadequate because, while you acknowledge the binder of CGMP records in your scrap yard, you did not
assess other documents found in the scrapyard, nor did you assess how poor documentation practices affected distributed
drug product or how you would strengthen your QU oversight.
Your firm’s quality systems are inadequate. See FDA’s guidance document Quality Systems Approach to Pharmaceutical
CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of
CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download
(h�ps://www.fda.gov/media/71023/download%0d)

2. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its
components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR
211.192).

Your firm’s investigations of out-of-specification (OOS) results were closed without adequate scientific justification.
For example, you opened an OOS investigation for (b)(4) USP active pharmaceutical ingredient (API) for an unknown
impurity which exceeded your specification. Your investigation identified an “old reagent” as a root cause, despite your
inability to reproduce the unknown impurity. You subsequently retested a new sample with fresh reagents and used the
passing results to release the API for use in producing your (b)(4) USP drug product. You did not evaluate the original
failing API sample. Your root cause determination and investigation were not scientifically justified.
In your response you acknowledged that the original sample should have been tested as part of your investigation to
determine a root cause and that the final root cause was not definitively concluded. You analyzed reserve samples for the
lots of drug product manufactured with the API and found them to meet specifications. You also provided a retrospective
review for all of your previous “invalidated” OOS results for products manufactured between January 2017 and March
2019.
Your response is inadequate. You failed to include the data that supports your reserve sample testing for batches
manufactured containing the lot of API identified in your OOS investigation. In addition, you identified nine additional
OOS investigations in which your root cause determination and investigation were not scientifically justified. You did not
extend your investigation to include any associated reserve samples of batches that may have been manufactured using
OOS materials.
In response to this letter:

For any OOS results with inconclusive or no root cause identified in the laboratory, include a thorough
review of production (e.g., batch manufacturing records, adequacy of the manufacturing steps, raw
materials, process capability, deviation history, batch failure history). Provide a corrective action and
preventive action (CAPA) plan that identifies root causes and specifies meaningful improvements.

Provide all reserve sample testing results. Include all analytical data for the API and drug product batches,
including any batches manufactured using API with associated OOS results with inconclusive or no root
cause.

For more information about proper handling of OOS results and documenting your investigations, refer to the FDA
guidance for industry Investigating OOS Test Results for Pharmaceutical Production at

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070287.pdf
(h�ps://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInforma�on/Guidances/UCM070287.pdf)

Data Integrity Remediation

[https://www.fda.gov/media/71023/download%0d](https://www.fda.gov/media/71023/download%0d)

[https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070287.pdf](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070287.pdf)

1/12/2020 Strides Pharma Science Limited – 576722 – 07/01/2019 | FDA

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/strides-pharma-science-limited-576722-07012019 4/5

Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and
quality of the drugs you manufacture. See FDA’s guidance document Data Integrity and Compliance With Drug CGMP
for guidance on establishing and following CGMP-compliant data integrity practices
at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM495891.pdf
(h�ps://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInforma�on/Guidances/UCM495891.pdf)

We strongly recommend that you retain a qualified consultant to assist in your remediation.

In response to this letter, provide the following:

A. An assessment of the extent of data integrity deficiencies at your facility. Identify omissions, alterations, deletions,
record destruction, non-contemporaneous record completion, and other deficiencies. Describe all parts of your
facility’s operations in which you discovered data integrity lapses.

B. A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your
assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data
integrity and analyses of the risks posed by ongoing operations.

C. A management strategy for your firm that includes the details of your global corrective action and preventive action
plan. The detailed corrective action plan should describe how you intend to ensure the reliability and completeness
of all data generated by your firm, including microbiological and analytical data, manufacturing records, and all
data submitted to FDA.

Conclusion
Violations cited in this letter are not intended as an all-inclusive list. You are responsible for investigating these
violations, for determining the causes, for preventing their recurrence, and for preventing other violations in all your
facilities.
If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA
requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can
work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug
Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your
drug manufacture under 21 U.S.C. 356C(b) and allows FDA to consider, as soon as possible, what actions, if any, may be
needed to avoid shortages and protect the health of patients who depend on your products.
Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of
any new applications or supplements listing your firm as a drug manufacturer.
Failure to correct these violations may also result in FDA refusing admission of articles manufactured at Strides Pharma
Science Limited, FEI 3012448465, at Unit-II, R. S. No.: 32, 33 & 34 PIMS Road Periyakalapet, Puducherry into the
United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Under the same authority, articles may be
subject to refusal of admission, in that the methods and controls used in their manufacture do not appear to conform to
CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done since
our inspection to correct your violations and to prevent their recurrence. If you cannot complete corrective actions within
15 working days, state your reasons for delay and your schedule for completion.
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov (mailto:CDER-OC-OMQ-

Communica�ons@fda.hhs.gov) or mail your reply to:

Carla Norris

Compliance Officer

[https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM495891.pdf](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM495891.pdf)

[mailto:CDER-OC-OMQ-Communications@fda.hhs.gov](mailto:CDER-OC-OMQ-Communications@fda.hhs.gov)

1/12/2020 Strides Pharma Science Limited – 576722 – 07/01/2019 | FDA

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/strides-pharma-science-limited-576722-07012019 5/5

U.S. Food and Drug Administration

White Oak Building 51, Room 4359

10903 New Hampshire Avenue

Silver Spring, MD 20993

USA

Please identify your response with FEI 3012448465.

Sincerely,

/S/

Francis Godwin

Director

Office of Manufacturing Quality

Office of Compliance

Center for Drug Evaluation and Research

cc:
Mr. Umesh Kale
President & Chief Quality Officer

Strides Pharma Science Limited

Strides House, Bilekahalli

Bannerghatta Road

Bangalore 560076

India

 More Warning Letters (/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters)

[https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters)

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**## GRLASSIGNMENTNUMBER2.docx**

Version 10

**Homework Assignment 2**

Pathway for Patient Health

Global Regulatory and Legal Requirements of Quality

| |
| — |
| **Complete this assignment by typing your answers into this Word document** |

First Name:

Last Name:

Email address:

· Save this file as: First Name Last Name GRLR Project 2 (e.g. Marla Phillips GRLR Project 2.doc)

· Submit this assignment in Canvas

· Assignment due dates are as listed in the syllabus.

· Generative AI use is not allowed on this assignment.

| |
| — |
| **This assignment must be submitted by the due date that was provided to you by 11:59pm (EST)** |

**Review the Warning Letter issued to Strides Pharmaceutical by the FDA on July 1, 2019.**

**Resources** you will need for this Assignment:

· As the warning letter under review in this assignment may not be available on the active
[www.FDA.gov](http://www.fda.gov/) website, a copy has been provided in your class materials.

· The 2022 FDA Out-of-Specification Guidance.
[https://www.fda.gov/media/158416/download](https://www.fda.gov/media/158416/download)

**Questions:**

1. Explain why the “Quality System” was determined to be inadequate by the FDA. Provide evidence from the Warning Letter to support your response. Identify 3 sections of 21CFR211 (Title 21 of the Code of Federal Regulation, Part 211) that you feel were violated, and explain why.

(
**Hint:** See the assignment rubric below to ensure that you are providing a complete answer.)

2. After reviewing the 2022 FDA Guidance on handling out of specification test results (only need to read sections I – IV.B.1), what should Strides Pharmaceuticals have done to investigate their failing results? Provide a brief explanation of the steps they should have taken.

(
**Hint:** See the assignment rubric below to ensure that you are providing a complete answer.)

3. Practice looking up warning letters on the FDA.gov website.

a. Find the FDA searchable Warning Letter database page.

b. Provide the following information for the most recent Warning letter issued by the Center of Drug Evaluation and Research (CDER).

i. Link to warning letter:

ii. Company name:

iii. List the violation(s) cited and the referenced regulations (if there are more than two violations sited, just provide information on two):

(Note: This will look something like this:

_Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a))._

-or, for another example:

_Your product is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a)._)

| | |
| — | — |
| **Grading Comments for Question 1** | **Score for Question 1**<br>**(Possible 4)** |
| | |

| | |
| — | — |
| **Grading Comments for Question 2** | **Score for Question 2**<br>**(Possible 4)** |
| | |

| | |
| — | — |
| **Grading Comments for Question 3** | **Score for Question 2**<br>**(Possible 2)** |
| | |

**Rubric:**

| | | | | |
| — | — | — | — | — |
| | **Does not meet requirements** | **Some requirements met** | **Good** | **Excellent** |
| **Questions 1** | No engagement/effort with this question. (0)<br>Use of AI (0) | The student identified some minimal examples of quality system violations, but did not provide CFR references or explanation. (1) | The student identified examples of quality system violations, provided CFR references, but did not explain how the CFR sections were violated. (2-3) | The student identified examples of quality system violations, provided CFR references, and explained how the CFR sections were violated. (4) |
| **Question 2** | No engagement/effort with this question. (0)<br>Use of AI (0) | The student attempted to identify what Stride should have done to investigate the failing results, but the explanation was inadequate, and the student did not describe the steps. (1) | The student identified what Stride should have done to investigate the failing results, but did not describe the steps. (2-3) | The student identified what Stride should have done to investigate the failing results, and described the steps (4) |
| **Question 3** | No engagement/effort with this question. (0)<br>Use of AI (0) | The student provides a reference to a warning letter from an FDA Center other than CDER (0.5) | The student identifies and references a CDER issued warning letter but does not accurately identify the violations and CFR references. (1-1.5) | The student identifies and references a CDER issued warning letter and correctly provides the requested information. (2) |

Marla A. Phillips, Ph.D. | CEO and President | Pathway for Patient Health

Marla.Phillips@Pathway4PH.org | 513-238-4338 | www.Pathway4PH.org

## image1.png

**## GRLR-HomeworkAssignment2-supportingdocument-StridePharmaceuticalWL.pdf**

1/12/2020 Strides Pharma Science Limited – 576722 – 07/01/2019 | FDA

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/strides-pharma-science-limited-576722-07012019 1/5

WARNING LETTER

Strides Pharma Science Limited
MARCS-CMS 576722 — JULY 01, 2019

Delivery Method:

UPS

Product:

Drugs

UPS Warning Letter 320-19-28

Return Receipt Requested

July 01, 2019

Mr. Arun Kumar

Chief Executive Officer/Managing Director

Recipient:

Mr. Arun Kumar

Chief Executive O�cer/Managing Director

Strides Pharma Science Limited

Strides House, Bilekahalli
Bannerghatta Road
Bangalore 560076
India

Issuing O�ce:

Center for Drug Evaluation and Research

10903 New Hampshire Avenue
Silver Spring, MD 20993
United States

1/12/2020 Strides Pharma Science Limited – 576722 – 07/01/2019 | FDA

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/strides-pharma-science-limited-576722-07012019 2/5

Strides Pharma Science Limited

Strides House, Bilekahalli

Bannerghatta Road

Bangalore 560076

India

Dear Mr. Kumar:

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Strides Pharma Science
Limited at Unit-II, R. S. No.: 32, 33 & 34 PIMS Road Periyakalapet, Puducherry, from January 28 to February 5, 2019.

This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for
finished pharmaceuticals. See 21 CFR, parts 210 and 211.

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to
CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

We reviewed your February 26, 2019, response in detail and acknowledge receipt of your subsequent correspondence.

During our inspection, our investigators observed specific violations including, but not limited to, the following.

1. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve
or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling,
and drug products (21 CFR 211.22(a)).

Your quality unit (QU) lacks appropriate responsibility and control over your drug manufacturing operations.
During the inspection, our investigator observed discarded CGMP documents and evidence of uncontrolled shredding of
documents. For example, multiple bags of uncontrolled CGMP documents with color coding indicating they were from
drug production, quality, and laboratory operations were awaiting shredding. Our investigator also found a blue binder
containing CGMP records, including batch records for U.S. drug products, discarded with other records in a 55-gallon
drum in your scrap yard. CGMP documents in the binder were dated as recently as January 21, 2019: seven days before
our inspection. Your QU did not review or check these documents prior to disposal.
Your QU is responsible for the oversight of your drug manufacturing operations, including the review and approval of
documents and document controls, to ensure a complete contemporaneous record of each batch of drug product
manufactured. That record is retained for CGMP purposes including annual review. In addition, your QU is responsible
for ensuring your production areas are adequately monitored and that employees understand your firm’s procedures and
their assigned tasks.
The uncontrolled destruction of CGMP records, and your lack of adequate documentation practices, raise questions about
the effectiveness of your QU and the integrity and accuracy of your CGMP records.
In your response you state the binder of CGMP documents in your scrap yard was “inadvertently come [sic] to scrap
yard” and that you were investigating the issue. You also committed to using bound log books and restricting printing to
reduce uncontrolled documents. In addition, you committed to strengthen your training program to include instructor-led
classes geared towards good documentation practices.

1/12/2020 Strides Pharma Science Limited – 576722 – 07/01/2019 | FDA

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/strides-pharma-science-limited-576722-07012019 3/5

Your response is inadequate because, while you acknowledge the binder of CGMP records in your scrap yard, you did not
assess other documents found in the scrapyard, nor did you assess how poor documentation practices affected distributed
drug product or how you would strengthen your QU oversight.
Your firm’s quality systems are inadequate. See FDA’s guidance document Quality Systems Approach to Pharmaceutical
CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of
CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download
(h�ps://www.fda.gov/media/71023/download%0d)

2. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its
components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR
211.192).

Your firm’s investigations of out-of-specification (OOS) results were closed without adequate scientific justification.
For example, you opened an OOS investigation for (b)(4) USP active pharmaceutical ingredient (API) for an unknown
impurity which exceeded your specification. Your investigation identified an “old reagent” as a root cause, despite your
inability to reproduce the unknown impurity. You subsequently retested a new sample with fresh reagents and used the
passing results to release the API for use in producing your (b)(4) USP drug product. You did not evaluate the original
failing API sample. Your root cause determination and investigation were not scientifically justified.
In your response you acknowledged that the original sample should have been tested as part of your investigation to
determine a root cause and that the final root cause was not definitively concluded. You analyzed reserve samples for the
lots of drug product manufactured with the API and found them to meet specifications. You also provided a retrospective
review for all of your previous “invalidated” OOS results for products manufactured between January 2017 and March
2019.
Your response is inadequate. You failed to include the data that supports your reserve sample testing for batches
manufactured containing the lot of API identified in your OOS investigation. In addition, you identified nine additional
OOS investigations in which your root cause determination and investigation were not scientifically justified. You did not
extend your investigation to include any associated reserve samples of batches that may have been manufactured using
OOS materials.
In response to this letter:

For any OOS results with inconclusive or no root cause identified in the laboratory, include a thorough
review of production (e.g., batch manufacturing records, adequacy of the manufacturing steps, raw
materials, process capability, deviation history, batch failure history). Provide a corrective action and
preventive action (CAPA) plan that identifies root causes and specifies meaningful improvements.

Provide all reserve sample testing results. Include all analytical data for the API and drug product batches,
including any batches manufactured using API with associated OOS results with inconclusive or no root
cause.

For more information about proper handling of OOS results and documenting your investigations, refer to the FDA
guidance for industry Investigating OOS Test Results for Pharmaceutical Production at

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070287.pdf
(h�ps://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInforma�on/Guidances/UCM070287.pdf)

Data Integrity Remediation

[https://www.fda.gov/media/71023/download%0d](https://www.fda.gov/media/71023/download%0d)

[https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070287.pdf](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070287.pdf)

1/12/2020 Strides Pharma Science Limited – 576722 – 07/01/2019 | FDA

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/strides-pharma-science-limited-576722-07012019 4/5

Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and
quality of the drugs you manufacture. See FDA’s guidance document Data Integrity and Compliance With Drug CGMP
for guidance on establishing and following CGMP-compliant data integrity practices
at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM495891.pdf
(h�ps://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInforma�on/Guidances/UCM495891.pdf)

We strongly recommend that you retain a qualified consultant to assist in your remediation.

In response to this letter, provide the following:

A. An assessment of the extent of data integrity deficiencies at your facility. Identify omissions, alterations, deletions,
record destruction, non-contemporaneous record completion, and other deficiencies. Describe all parts of your
facility’s operations in which you discovered data integrity lapses.

B. A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your
assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data
integrity and analyses of the risks posed by ongoing operations.

C. A management strategy for your firm that includes the details of your global corrective action and preventive action
plan. The detailed corrective action plan should describe how you intend to ensure the reliability and completeness
of all data generated by your firm, including microbiological and analytical data, manufacturing records, and all
data submitted to FDA.

Conclusion
Violations cited in this letter are not intended as an all-inclusive list. You are responsible for investigating these
violations, for determining the causes, for preventing their recurrence, and for preventing other violations in all your
facilities.
If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA
requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can
work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug
Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your
drug manufacture under 21 U.S.C. 356C(b) and allows FDA to consider, as soon as possible, what actions, if any, may be
needed to avoid shortages and protect the health of patients who depend on your products.
Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of
any new applications or supplements listing your firm as a drug manufacturer.
Failure to correct these violations may also result in FDA refusing admission of articles manufactured at Strides Pharma
Science Limited, FEI 3012448465, at Unit-II, R. S. No.: 32, 33 & 34 PIMS Road Periyakalapet, Puducherry into the
United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Under the same authority, articles may be
subject to refusal of admission, in that the methods and controls used in their manufacture do not appear to conform to
CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done since
our inspection to correct your violations and to prevent their recurrence. If you cannot complete corrective actions within
15 working days, state your reasons for delay and your schedule for completion.
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov (mailto:CDER-OC-OMQ-

Communica�ons@fda.hhs.gov) or mail your reply to:

Carla Norris

Compliance Officer

[https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM495891.pdf](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM495891.pdf)

[mailto:CDER-OC-OMQ-Communications@fda.hhs.gov](mailto:CDER-OC-OMQ-Communications@fda.hhs.gov)

1/12/2020 Strides Pharma Science Limited – 576722 – 07/01/2019 | FDA

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/strides-pharma-science-limited-576722-07012019 5/5

U.S. Food and Drug Administration

White Oak Building 51, Room 4359

10903 New Hampshire Avenue

Silver Spring, MD 20993

USA

Please identify your response with FEI 3012448465.

Sincerely,

/S/

Francis Godwin

Director

Office of Manufacturing Quality

Office of Compliance

Center for Drug Evaluation and Research

cc:
Mr. Umesh Kale
President & Chief Quality Officer

Strides Pharma Science Limited

Strides House, Bilekahalli

Bannerghatta Road

Bangalore 560076

India

 More Warning Letters (/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters)

[https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters)

**GRLR-HomeworkAssignment2-supportingdocument-2022FDAOutofSpecificationguidance.pdf**

This file is too large to display. [View in new window](https://www.sweetstudy.com/files/grlr-homeworkassignment2-supportingdocument-2022fdaoutofspecificationguidance-pdf)

**## GRLASSIGNMENTNUMBER2.docx**

Version 10

**Homework Assignment 2**

Pathway for Patient Health

Global Regulatory and Legal Requirements of Quality

| |
| — |
| **Complete this assignment by typing your answers into this Word document** |

First Name:

Last Name:

Email address:

· Save this file as: First Name Last Name GRLR Project 2 (e.g. Marla Phillips GRLR Project 2.doc)

· Submit this assignment in Canvas

· Assignment due dates are as listed in the syllabus.

· Generative AI use is not allowed on this assignment.

| |
| — |
| **This assignment must be submitted by the due date that was provided to you by 11:59pm (EST)** |

**Review the Warning Letter issued to Strides Pharmaceutical by the FDA on July 1, 2019.**

**Resources** you will need for this Assignment:

· As the warning letter under review in this assignment may not be available on the active
[www.FDA.gov](http://www.fda.gov/) website, a copy has been provided in your class materials.

· The 2022 FDA Out-of-Specification Guidance.
[https://www.fda.gov/media/158416/download](https://www.fda.gov/media/158416/download)

**Questions:**

1. Explain why the “Quality System” was determined to be inadequate by the FDA. Provide evidence from the Warning Letter to support your response. Identify 3 sections of 21CFR211 (Title 21 of the Code of Federal Regulation, Part 211) that you feel were violated, and explain why.

(
**Hint:** See the assignment rubric below to ensure that you are providing a complete answer.)

2. After reviewing the 2022 FDA Guidance on handling out of specification test results (only need to read sections I – IV.B.1), what should Strides Pharmaceuticals have done to investigate their failing results? Provide a brief explanation of the steps they should have taken.

(
**Hint:** See the assignment rubric below to ensure that you are providing a complete answer.)

3. Practice looking up warning letters on the FDA.gov website.

a. Find the FDA searchable Warning Letter database page.

b. Provide the following information for the most recent Warning letter issued by the Center of Drug Evaluation and Research (CDER).

i. Link to warning letter:

ii. Company name:

iii. List the violation(s) cited and the referenced regulations (if there are more than two violations sited, just provide information on two):

(Note: This will look something like this:

_Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a))._

-or, for another example:

_Your product is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a)._)

| | |
| — | — |
| **Grading Comments for Question 1** | **Score for Question 1**<br>**(Possible 4)** |
| | |

| | |
| — | — |
| **Grading Comments for Question 2** | **Score for Question 2**<br>**(Possible 4)** |
| | |

| | |
| — | — |
| **Grading Comments for Question 3** | **Score for Question 2**<br>**(Possible 2)** |
| | |

**Rubric:**

| | | | | |
| — | — | — | — | — |
| | **Does not meet requirements** | **Some requirements met** | **Good** | **Excellent** |
| **Questions 1** | No engagement/effort with this question. (0)<br>Use of AI (0) | The student identified some minimal examples of quality system violations, but did not provide CFR references or explanation. (1) | The student identified examples of quality system violations, provided CFR references, but did not explain how the CFR sections were violated. (2-3) | The student identified examples of quality system violations, provided CFR references, and explained how the CFR sections were violated. (4) |
| **Question 2** | No engagement/effort with this question. (0)<br>Use of AI (0) | The student attempted to identify what Stride should have done to investigate the failing results, but the explanation was inadequate, and the student did not describe the steps. (1) | The student identified what Stride should have done to investigate the failing results, but did not describe the steps. (2-3) | The student identified what Stride should have done to investigate the failing results, and described the steps (4) |
| **Question 3** | No engagement/effort with this question. (0)<br>Use of AI (0) | The student provides a reference to a warning letter from an FDA Center other than CDER (0.5) | The student identifies and references a CDER issued warning letter but does not accurately identify the violations and CFR references. (1-1.5) | The student identifies and references a CDER issued warning letter and correctly provides the requested information. (2) |

Marla A. Phillips, Ph.D. | CEO and President | Pathway for Patient Health

Marla.Phillips@Pathway4PH.org | 513-238-4338 | www.Pathway4PH.org

## image1.png

**## GRLR-HomeworkAssignment2-supportingdocument-StridePharmaceuticalWL.pdf**

1/12/2020 Strides Pharma Science Limited – 576722 – 07/01/2019 | FDA

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/strides-pharma-science-limited-576722-07012019 1/5

WARNING LETTER

Strides Pharma Science Limited
MARCS-CMS 576722 — JULY 01, 2019

Delivery Method:

UPS

Product:

Drugs

UPS Warning Letter 320-19-28

Return Receipt Requested

July 01, 2019

Mr. Arun Kumar

Chief Executive Officer/Managing Director

Recipient:

Mr. Arun Kumar

Chief Executive O�cer/Managing Director

Strides Pharma Science Limited

Strides House, Bilekahalli
Bannerghatta Road
Bangalore 560076
India

Issuing O�ce:

Center for Drug Evaluation and Research

10903 New Hampshire Avenue
Silver Spring, MD 20993
United States

1/12/2020 Strides Pharma Science Limited – 576722 – 07/01/2019 | FDA

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/strides-pharma-science-limited-576722-07012019 2/5

Strides Pharma Science Limited

Strides House, Bilekahalli

Bannerghatta Road

Bangalore 560076

India

Dear Mr. Kumar:

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Strides Pharma Science
Limited at Unit-II, R. S. No.: 32, 33 & 34 PIMS Road Periyakalapet, Puducherry, from January 28 to February 5, 2019.

This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for
finished pharmaceuticals. See 21 CFR, parts 210 and 211.

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to
CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

We reviewed your February 26, 2019, response in detail and acknowledge receipt of your subsequent correspondence.

During our inspection, our investigators observed specific violations including, but not limited to, the following.

1. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve
or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling,
and drug products (21 CFR 211.22(a)).

Your quality unit (QU) lacks appropriate responsibility and control over your drug manufacturing operations.
During the inspection, our investigator observed discarded CGMP documents and evidence of uncontrolled shredding of
documents. For example, multiple bags of uncontrolled CGMP documents with color coding indicating they were from
drug production, quality, and laboratory operations were awaiting shredding. Our investigator also found a blue binder
containing CGMP records, including batch records for U.S. drug products, discarded with other records in a 55-gallon
drum in your scrap yard. CGMP documents in the binder were dated as recently as January 21, 2019: seven days before
our inspection. Your QU did not review or check these documents prior to disposal.
Your QU is responsible for the oversight of your drug manufacturing operations, including the review and approval of
documents and document controls, to ensure a complete contemporaneous record of each batch of drug product
manufactured. That record is retained for CGMP purposes including annual review. In addition, your QU is responsible
for ensuring your production areas are adequately monitored and that employees understand your firm’s procedures and
their assigned tasks.
The uncontrolled destruction of CGMP records, and your lack of adequate documentation practices, raise questions about
the effectiveness of your QU and the integrity and accuracy of your CGMP records.
In your response you state the binder of CGMP documents in your scrap yard was “inadvertently come [sic] to scrap
yard” and that you were investigating the issue. You also committed to using bound log books and restricting printing to
reduce uncontrolled documents. In addition, you committed to strengthen your training program to include instructor-led
classes geared towards good documentation practices.

1/12/2020 Strides Pharma Science Limited – 576722 – 07/01/2019 | FDA

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/strides-pharma-science-limited-576722-07012019 3/5

Your response is inadequate because, while you acknowledge the binder of CGMP records in your scrap yard, you did not
assess other documents found in the scrapyard, nor did you assess how poor documentation practices affected distributed
drug product or how you would strengthen your QU oversight.
Your firm’s quality systems are inadequate. See FDA’s guidance document Quality Systems Approach to Pharmaceutical
CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of
CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download
(h�ps://www.fda.gov/media/71023/download%0d)

2. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its
components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR
211.192).

Your firm’s investigations of out-of-specification (OOS) results were closed without adequate scientific justification.
For example, you opened an OOS investigation for (b)(4) USP active pharmaceutical ingredient (API) for an unknown
impurity which exceeded your specification. Your investigation identified an “old reagent” as a root cause, despite your
inability to reproduce the unknown impurity. You subsequently retested a new sample with fresh reagents and used the
passing results to release the API for use in producing your (b)(4) USP drug product. You did not evaluate the original
failing API sample. Your root cause determination and investigation were not scientifically justified.
In your response you acknowledged that the original sample should have been tested as part of your investigation to
determine a root cause and that the final root cause was not definitively concluded. You analyzed reserve samples for the
lots of drug product manufactured with the API and found them to meet specifications. You also provided a retrospective
review for all of your previous “invalidated” OOS results for products manufactured between January 2017 and March
2019.
Your response is inadequate. You failed to include the data that supports your reserve sample testing for batches
manufactured containing the lot of API identified in your OOS investigation. In addition, you identified nine additional
OOS investigations in which your root cause determination and investigation were not scientifically justified. You did not
extend your investigation to include any associated reserve samples of batches that may have been manufactured using
OOS materials.
In response to this letter:

For any OOS results with inconclusive or no root cause identified in the laboratory, include a thorough
review of production (e.g., batch manufacturing records, adequacy of the manufacturing steps, raw
materials, process capability, deviation history, batch failure history). Provide a corrective action and
preventive action (CAPA) plan that identifies root causes and specifies meaningful improvements.

Provide all reserve sample testing results. Include all analytical data for the API and drug product batches,
including any batches manufactured using API with associated OOS results with inconclusive or no root
cause.

For more information about proper handling of OOS results and documenting your investigations, refer to the FDA
guidance for industry Investigating OOS Test Results for Pharmaceutical Production at

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070287.pdf
(h�ps://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInforma�on/Guidances/UCM070287.pdf)

Data Integrity Remediation

[https://www.fda.gov/media/71023/download%0d](https://www.fda.gov/media/71023/download%0d)

[https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070287.pdf](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070287.pdf)

1/12/2020 Strides Pharma Science Limited – 576722 – 07/01/2019 | FDA

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/strides-pharma-science-limited-576722-07012019 4/5

Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and
quality of the drugs you manufacture. See FDA’s guidance document Data Integrity and Compliance With Drug CGMP
for guidance on establishing and following CGMP-compliant data integrity practices
at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM495891.pdf
(h�ps://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInforma�on/Guidances/UCM495891.pdf)

We strongly recommend that you retain a qualified consultant to assist in your remediation.

In response to this letter, provide the following:

A. An assessment of the extent of data integrity deficiencies at your facility. Identify omissions, alterations, deletions,
record destruction, non-contemporaneous record completion, and other deficiencies. Describe all parts of your
facility’s operations in which you discovered data integrity lapses.

B. A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your
assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data
integrity and analyses of the risks posed by ongoing operations.

C. A management strategy for your firm that includes the details of your global corrective action and preventive action
plan. The detailed corrective action plan should describe how you intend to ensure the reliability and completeness
of all data generated by your firm, including microbiological and analytical data, manufacturing records, and all
data submitted to FDA.

Conclusion
Violations cited in this letter are not intended as an all-inclusive list. You are responsible for investigating these
violations, for determining the causes, for preventing their recurrence, and for preventing other violations in all your
facilities.
If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA
requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can
work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug
Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your
drug manufacture under 21 U.S.C. 356C(b) and allows FDA to consider, as soon as possible, what actions, if any, may be
needed to avoid shortages and protect the health of patients who depend on your products.
Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of
any new applications or supplements listing your firm as a drug manufacturer.
Failure to correct these violations may also result in FDA refusing admission of articles manufactured at Strides Pharma
Science Limited, FEI 3012448465, at Unit-II, R. S. No.: 32, 33 & 34 PIMS Road Periyakalapet, Puducherry into the
United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Under the same authority, articles may be
subject to refusal of admission, in that the methods and controls used in their manufacture do not appear to conform to
CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done since
our inspection to correct your violations and to prevent their recurrence. If you cannot complete corrective actions within
15 working days, state your reasons for delay and your schedule for completion.
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov (mailto:CDER-OC-OMQ-

Communica�ons@fda.hhs.gov) or mail your reply to:

Carla Norris

Compliance Officer

[https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM495891.pdf](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM495891.pdf)

[mailto:CDER-OC-OMQ-Communications@fda.hhs.gov](mailto:CDER-OC-OMQ-Communications@fda.hhs.gov)

1/12/2020 Strides Pharma Science Limited – 576722 – 07/01/2019 | FDA

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/strides-pharma-science-limited-576722-07012019 5/5

U.S. Food and Drug Administration

White Oak Building 51, Room 4359

10903 New Hampshire Avenue

Silver Spring, MD 20993

USA

Please identify your response with FEI 3012448465.

Sincerely,

/S/

Francis Godwin

Director

Office of Manufacturing Quality

Office of Compliance

Center for Drug Evaluation and Research

cc:
Mr. Umesh Kale
President & Chief Quality Officer

Strides Pharma Science Limited

Strides House, Bilekahalli

Bannerghatta Road

Bangalore 560076

India

 More Warning Letters (/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters)

[https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters)

**GRLR-HomeworkAssignment2-supportingdocument-2022FDAOutofSpecificationguidance.pdf**

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