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Sub System /
Stability Studies
Stability Studies
View Detailed Analysis

Analytics Overview

53
Form 483s Issued
16
483s converted to WL
62
Total Observation
Form 483s Issued
+74 from last period

Analytics Overview

Form 483 Conversion Rate by Year
Form 483s Issued (Yearly)

Recent Form 483s & Warning Letters

View all 483’s
Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
17 Jul 2025
Lupin Limited
Drugs
View Form 483
11 Jul 2025
Center for Drug Evaluation and Research
Drugs
View Form 483
27 Jun 2025
BSO, LLC
Drugs
View Form 483
13 Jun 2025
Sun Pharmaceutical Industries Ltd.
Drugs
View Form 483
31 May 2025
Alembic Pharmaceuticals Limited (Units I and II)
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
6
3
Justin A Boyd
5
4
Anastasia M Shields
4
4
Crystal Monroy
4
2
Arsen Karapetyan
3
1

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications
Lupin Limited		 17 Jul 2025 Normal Justification: Stability Studies is implicated as affected batches weren't evaluated for impact on quality over time post-deviation.
Excerpt: failed to place the affected batches on stability testing program to evaluate the potential impact
View Details
Your firm failed to establish an adequate written testing program to assess the stability characteristics of drug products.
Center for Drug Evaluation and Research		 11 Jul 2025 Normal Justification: Stability Studies process type is directly linked to the issue as the oversight occurred in the execution of stability testing protocols.
Excerpt: The stability studies conducted for Hydrocodone Bitartrate and Acetaminophen Tablets USP 10 mg/325 mg did not include testing for dissolution.
View Details
The written stability program for drug products does not include specific test methods.
BSO, LLC		 27 Jun 2025 Normal Justification: Stability studies ensure drug products maintain quality over time. Missing tests (photostability, dissolution, impurities) affect this process.
Excerpt: Stability Study BSO.SS.001 does not contain any data to demonstrate that the packaging protects the drug from photodegradation.
View Details
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Sun Pharmaceutical Industries Ltd.		 13 Jun 2025 Normal Justification: Failure in monitoring and responding to stability data trends directly affects the integrity of stability studies.
Excerpt: Your Quality Unit did not investigate out of trend test results of an annual stability batch...
View Details
Laboratory control does not include establishment of scientifically sound and appropriate test procedures and specifications
Alembic Pharmaceuticals Limited (Units I and II)		 31 May 2025 Normal Justification: The observation specifically highlights inadequacies in the stability testing methods and degradation data that directly relate to the Stability Studies process type.
Excerpt: Analytical test procedures used to perform stability testing on APIs ... are not adequately validated as stability indicating.
View Details

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Go back

Stability Studies

Explore essential insights on batch release processes to enhance compliance and quality. Dive into our article for practical guidance and best practices.

Written By
Vivek Gera
Reading Time
8
Minutes
Share

Stability Studies

Overview

53
Form 483s Issued
16
483s converted to WL
62
Total Observation
Form 483s Issued
+74 from last period

FDA Trends

Form 483 Conversion Rate by Year
Form 483s Issued (Yearly)

Recent Form 483s & Warning Letters

Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
17 Jul 2025
Lupin Limited
Drugs
View Form 483
11 Jul 2025
Center for Drug Evaluation and Research
Drugs
View Form 483
27 Jun 2025
BSO, LLC
Drugs
View Form 483
13 Jun 2025
Sun Pharmaceutical Industries Ltd.
Drugs
View Form 483
31 May 2025
Alembic Pharmaceuticals Limited (Units I and II)
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
6
3
Justin A Boyd
5
4
Anastasia M Shields
4
4
Crystal Monroy
4
2
Arsen Karapetyan
3
1

Key Observations

TITLE/ COMPANY Issue Date Status Details
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications
Lupin Limited		 17 Jul 2025 Normal Justification: Stability Studies is implicated as affected batches weren't evaluated for impact on quality over time post-deviation.
Excerpt: failed to place the affected batches on stability testing program to evaluate the potential impact
View Details
Your firm failed to establish an adequate written testing program to assess the stability characteristics of drug products.
Center for Drug Evaluation and Research		 11 Jul 2025 Normal Justification: Stability Studies process type is directly linked to the issue as the oversight occurred in the execution of stability testing protocols.
Excerpt: The stability studies conducted for Hydrocodone Bitartrate and Acetaminophen Tablets USP 10 mg/325 mg did not include testing for dissolution.
View Details
The written stability program for drug products does not include specific test methods.
BSO, LLC		 27 Jun 2025 Normal Justification: Stability studies ensure drug products maintain quality over time. Missing tests (photostability, dissolution, impurities) affect this process.
Excerpt: Stability Study BSO.SS.001 does not contain any data to demonstrate that the packaging protects the drug from photodegradation.
View Details
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Sun Pharmaceutical Industries Ltd.		 13 Jun 2025 Normal Justification: Failure in monitoring and responding to stability data trends directly affects the integrity of stability studies.
Excerpt: Your Quality Unit did not investigate out of trend test results of an annual stability batch...
View Details
Laboratory control does not include establishment of scientifically sound and appropriate test procedures and specifications
Alembic Pharmaceuticals Limited (Units I and II)		 31 May 2025 Normal Justification: The observation specifically highlights inadequacies in the stability testing methods and degradation data that directly relate to the Stability Studies process type.
Excerpt: Analytical test procedures used to perform stability testing on APIs ... are not adequately validated as stability indicating.
View Details

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