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Sub System /
Stability Studies
Stability Studies
View Detailed Analysis

Analytics Overview

62
Form 483s Issued
16
483s converted to WL
74
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
20 Feb 2026
Maiva Pharma Private Limited
Drugs
View Form 483
10 Feb 2026
Aurobindo Pharma Limited, Unit VII
Drugs
View Form 483
05 Jan 2026
Sato Pharmaceutical Co., Ltd.
Drugs
View Form 483
19 Dec 2025
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy
Drugs
View Form 483
05 Dec 2025
Ipca Laboratories Limited
Drugs
View Form 483

Top Investigators

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

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Failure to thoroughly review any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: The observation identifies issues in stability studies and HPLC analysis affecting component specifications.
Excerpt: Retesting confirmed the initial OOS assay results. However, the investigation does not provide documented evidence.
View 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 whether or not the batch has been already distributed.
Aurobindo Pharma Limited, Unit VII		 10 Feb 2026 Normal Justification: Delayed stability testing and continued analysis post-expiry jeopardize the integrity of Stability Studies process.
Excerpt: Your global procedure APL-GP-F-QC-GEN-0001 does not have a requirement for timely stability testing initiation.
View Details
The quality control unit lacks the responsibility and authority to approve and reject all drug products.
Sato Pharmaceutical Co., Ltd.		 05 Jan 2026 Normal Justification: The observation relates to stability testing, with the quality unit failing to respond appropriately to stability failure data.
Excerpt: Initiated OOS 2024-004 for failing stability sample test at the 24-month mark.
View Details
The written stability testing program is not followed.
Sato Pharmaceutical Co., Ltd.		 05 Jan 2026 Normal Justification: Stability Studies process type is affected as the observation highlights a failure to adhere to the stability testing schedule crucial for determining product shelf life.
Excerpt: Your firm revised procedure Document No. QTS-040: Stability Test Procedure to eliminate the 12-month stability testing time point without adequate scientific justification.
View Details
The written stability program for drug products does not include specific test methods.
Sato Pharmaceutical Co., Ltd.		 05 Jan 2026 Normal Justification: Stability Studies are directly affected as the omission of critical test parameters undermines evaluating product's stability.
Excerpt: Your stability testing program does not include complete test parameters necessary to adequately assess product stability characteristics.
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.

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Stability Studies

Overview

62
Form 483s Issued
16
483s converted to WL
74
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
20 Feb 2026
Maiva Pharma Private Limited
Drugs
View Form 483
10 Feb 2026
Aurobindo Pharma Limited, Unit VII
Drugs
View Form 483
05 Jan 2026
Sato Pharmaceutical Co., Ltd.
Drugs
View Form 483
19 Dec 2025
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy
Drugs
View Form 483
05 Dec 2025
Ipca Laboratories Limited
Drugs
View Form 483

Top FDA Investigators

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

Key Observations

TITLE/ COMPANY Issue Date Status Details
Failure to thoroughly review any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: The observation identifies issues in stability studies and HPLC analysis affecting component specifications.
Excerpt: Retesting confirmed the initial OOS assay results. However, the investigation does not provide documented evidence.
View 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 whether or not the batch has been already distributed.
Aurobindo Pharma Limited, Unit VII		 10 Feb 2026 Normal Justification: Delayed stability testing and continued analysis post-expiry jeopardize the integrity of Stability Studies process.
Excerpt: Your global procedure APL-GP-F-QC-GEN-0001 does not have a requirement for timely stability testing initiation.
View Details
The quality control unit lacks the responsibility and authority to approve and reject all drug products.
Sato Pharmaceutical Co., Ltd.		 05 Jan 2026 Normal Justification: The observation relates to stability testing, with the quality unit failing to respond appropriately to stability failure data.
Excerpt: Initiated OOS 2024-004 for failing stability sample test at the 24-month mark.
View Details
The written stability testing program is not followed.
Sato Pharmaceutical Co., Ltd.		 05 Jan 2026 Normal Justification: Stability Studies process type is affected as the observation highlights a failure to adhere to the stability testing schedule crucial for determining product shelf life.
Excerpt: Your firm revised procedure Document No. QTS-040: Stability Test Procedure to eliminate the 12-month stability testing time point without adequate scientific justification.
View Details
The written stability program for drug products does not include specific test methods.
Sato Pharmaceutical Co., Ltd.		 05 Jan 2026 Normal Justification: Stability Studies are directly affected as the omission of critical test parameters undermines evaluating product's stability.
Excerpt: Your stability testing program does not include complete test parameters necessary to adequately assess product stability characteristics.
View Details

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