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Sub System /
Stability Studies
Stability Studies
View Detailed Analysis

Analytics Overview

61
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
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
21 Nov 2025
Shilpa Medicare Limited
Drugs
View Form 483
14 Nov 2025
Empower Clinic Services, L.L.C. dba Empower Pharma
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
Arsen Karapetyan
3
1

Observations

View all Observations
TITLE/ COMPANY Issue Date Status 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
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 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
Written procedures are lacking which describe in sufficient detail the receipt, identification, sampling, testing and approval of components
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy		 19 Dec 2025 Normal Justification: Procedures for determining hold times and BUDs are an integral part of ensuring stability and product efficacy.
Excerpt: Does not have written procedures that specify the process and criteria for determining and documenting the appropriate hold times or Beyond Use Dates (BUDs).
View Details
There is no written testing program designed to assess the stability characteristics of drug products
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy		 19 Dec 2025 Normal Justification: The observation pinpointed missing protocols crucial for assessing stability and BUDs, fundamental to stability studies.
Excerpt: Your firm does not have a written stability testing program to determine Beyond Use Dates (BUD) placed on all your drug products.
View Details

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Uncover Trends: FDA Investigator profiles & Observations.
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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.

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Stability Studies

Overview

61
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
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
21 Nov 2025
Shilpa Medicare Limited
Drugs
View Form 483
14 Nov 2025
Empower Clinic Services, L.L.C. dba Empower Pharma
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
Arsen Karapetyan
3
1

Key Observations

TITLE/ COMPANY Issue Date Status 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
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 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
Written procedures are lacking which describe in sufficient detail the receipt, identification, sampling, testing and approval of components
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy		 19 Dec 2025 Normal Justification: Procedures for determining hold times and BUDs are an integral part of ensuring stability and product efficacy.
Excerpt: Does not have written procedures that specify the process and criteria for determining and documenting the appropriate hold times or Beyond Use Dates (BUDs).
View Details
There is no written testing program designed to assess the stability characteristics of drug products
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy		 19 Dec 2025 Normal Justification: The observation pinpointed missing protocols crucial for assessing stability and BUDs, fundamental to stability studies.
Excerpt: Your firm does not have a written stability testing program to determine Beyond Use Dates (BUD) placed on all your drug products.
View Details

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