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Sub System /
Stability Studies
Stability Studies
View Detailed Analysis

Analytics Overview

90
Form 483s Issued
16
483s converted to WL
103
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
01 May 2026
Alkem Laboratories Limited
Drugs
17 Apr 2026
Novel Laboratories, Inc. d.b.a Lupin
Drugs
27 Mar 2026
Bentley Laboratories LLC
Drugs
23 Mar 2026
Dr. J Skinclinic, Inc
Drugs
20 Mar 2026
Eosera, Inc.
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Anastasia M Shields
7
4
José E Melendez
6
3
Justin A Boyd
6
4
Crystal Monroy
5
2
Nibin Varghese
5
0
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
Alkem Laboratories Limited
01 May 2026 Normal Justification: Issues stem from ineffective stability evaluations, allowing trends to be overlooked until significant failures occur.
Excerpt: This batch failed again at 6-month long term stability timepoint due to individual unidentified impurity.
View Details
Investigations of an unexplained discrepancy and failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product.
Novel Laboratories, Inc. d.b.a Lupin
17 Apr 2026 Normal Justification: Stability studies were not adjusted to monitor impacts of ingredient aging behavior.
Excerpt: You did not place these batches on a stability program or conduct additional stability testing.
View Details
The written stability program for drug products does not include reliable, meaningful, and specific test methods.
Bentley Laboratories LLC
27 Mar 2026 Normal Justification: The lack of meaningful and specific test methods affects the integrity of 'Stability Studies'.
Excerpt: The written stability program for drug products does not include reliable, meaningful, and specific test methods.
View Details
Results of stability testing are not used in determining appropriate storage conditions and expiration dates.
Dr. J Skinclinic, Inc
23 Mar 2026 Normal Justification: Stability Studies directly relates as stability testing should impact storage condition and expiration decisions.
Excerpt: Results of stability testing are not used in determining appropriate storage conditions and expiration dates.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures
Eosera, Inc.
20 Mar 2026 Normal Justification: Stability study deficiencies highlighted by missing stability-indicating documentation.
Excerpt: No documentation to show that the test methods used for stability samples are stability-indicating.
View Details

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Stability Studies

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

Stability Studies

Overview

90
Form 483s Issued
16
483s converted to WL
103
Total Observation
Form 483s Issued
+74 from last period

Recent Form 483s & Warning Letters

Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
01 May 2026
Alkem Laboratories Limited
Drugs
17 Apr 2026
Novel Laboratories, Inc. d.b.a Lupin
Drugs
27 Mar 2026
Bentley Laboratories LLC
Drugs
23 Mar 2026
Dr. J Skinclinic, Inc
Drugs
20 Mar 2026
Eosera, Inc.
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Anastasia M Shields
7
4
José E Melendez
6
3
Justin A Boyd
6
4
Crystal Monroy
5
2
Nibin Varghese
5
0

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
Alkem Laboratories Limited
01 May 2026 Normal Justification: Issues stem from ineffective stability evaluations, allowing trends to be overlooked until significant failures occur.
Excerpt: This batch failed again at 6-month long term stability timepoint due to individual unidentified impurity.
View Details
Investigations of an unexplained discrepancy and failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product.
Novel Laboratories, Inc. d.b.a Lupin
17 Apr 2026 Normal Justification: Stability studies were not adjusted to monitor impacts of ingredient aging behavior.
Excerpt: You did not place these batches on a stability program or conduct additional stability testing.
View Details
The written stability program for drug products does not include reliable, meaningful, and specific test methods.
Bentley Laboratories LLC
27 Mar 2026 Normal Justification: The lack of meaningful and specific test methods affects the integrity of 'Stability Studies'.
Excerpt: The written stability program for drug products does not include reliable, meaningful, and specific test methods.
View Details
Results of stability testing are not used in determining appropriate storage conditions and expiration dates.
Dr. J Skinclinic, Inc
23 Mar 2026 Normal Justification: Stability Studies directly relates as stability testing should impact storage condition and expiration decisions.
Excerpt: Results of stability testing are not used in determining appropriate storage conditions and expiration dates.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures
Eosera, Inc.
20 Mar 2026 Normal Justification: Stability study deficiencies highlighted by missing stability-indicating documentation.
Excerpt: No documentation to show that the test methods used for stability samples are stability-indicating.
View Details

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