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Sub System /
Method Validation
Method Validation
View Detailed Analysis

Analytics Overview

54
Form 483s Issued
12
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
05 Jan 2026
Sato Pharmaceutical Co., Ltd.
Drugs
05 Dec 2025
Ipca Laboratories Limited
Drugs
21 Nov 2025
Lupin Limited
Drugs
21 Nov 2025
Shilpa Medicare Limited
Drugs
14 Nov 2025
Asahi Kasei Finechem Co., Ltd. Nobeoka Plant
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
9
3
Pratik S Upadhyay
5
0
Saleem A Akhtar
4
1
Justin A Boyd
4
1
David Carlson
3
0
TITLE/ COMPANY Issue Date Status Details
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
Sato Pharmaceutical Co., Ltd.
05 Jan 2026 Normal Justification: Method Validation is linked to the issue as the unidentified impurity suggests a lack of comprehensive validation and monitoring of impurities.
Excerpt: HPLC chromatographic analysis did not monitor or report an impurity peak consistently eluting before the main peak.
View Details
The suitability of analytical test methods is deficient for its intended use
Ipca Laboratories Limited
05 Dec 2025 Normal Justification: Method validation is crucial as the issue pertains to inadequate verification and lack of data supporting method accuracy.
Excerpt: The site failed to provide any scientific data generated through a controlled study to demonstrate that the HPLC column temperate range of (b) (4) C to (b) (4) C can generate reproduceable and accurate results.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures
Shilpa Medicare Limited
21 Nov 2025 Normal Justification: The issue centers on method equivalency and validation, directly related to "Method Validation" in the test procedures.
Excerpt: Your firm performed assays using both in house method and the compendial method and calculated relative standard deviation (RSD) for each method’s data.
View Details
The written stability program for drug products does not include reliable, meaningful, and specific test methods.
Shilpa Medicare Limited
21 Nov 2025 Normal Justification: Method Validation ensures analytical methods comply with current standards and practices.
Excerpt: Contracting laboratory revised their SOP for Analytical Method Validation/Verification.
View Details
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
Lupin Limited
21 Nov 2025 Normal Justification: Method validation directly affects result reliability and is compromised if initial validation is inadequate.
Excerpt: LC-MS/MS analytical test methods were validated ... observed sample test results of single batch were reported with variations.
View Details

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Method Validation

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

Method Validation

Overview

54
Form 483s Issued
12
483s converted to WL
62
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
05 Jan 2026
Sato Pharmaceutical Co., Ltd.
Drugs
05 Dec 2025
Ipca Laboratories Limited
Drugs
21 Nov 2025
Lupin Limited
Drugs
21 Nov 2025
Shilpa Medicare Limited
Drugs
14 Nov 2025
Asahi Kasei Finechem Co., Ltd. Nobeoka Plant
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
9
3
Pratik S Upadhyay
5
0
Saleem A Akhtar
4
1
Justin A Boyd
4
1
David Carlson
3
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
Sato Pharmaceutical Co., Ltd.
05 Jan 2026 Normal Justification: Method Validation is linked to the issue as the unidentified impurity suggests a lack of comprehensive validation and monitoring of impurities.
Excerpt: HPLC chromatographic analysis did not monitor or report an impurity peak consistently eluting before the main peak.
View Details
The suitability of analytical test methods is deficient for its intended use
Ipca Laboratories Limited
05 Dec 2025 Normal Justification: Method validation is crucial as the issue pertains to inadequate verification and lack of data supporting method accuracy.
Excerpt: The site failed to provide any scientific data generated through a controlled study to demonstrate that the HPLC column temperate range of (b) (4) C to (b) (4) C can generate reproduceable and accurate results.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures
Shilpa Medicare Limited
21 Nov 2025 Normal Justification: The issue centers on method equivalency and validation, directly related to "Method Validation" in the test procedures.
Excerpt: Your firm performed assays using both in house method and the compendial method and calculated relative standard deviation (RSD) for each method’s data.
View Details
The written stability program for drug products does not include reliable, meaningful, and specific test methods.
Shilpa Medicare Limited
21 Nov 2025 Normal Justification: Method Validation ensures analytical methods comply with current standards and practices.
Excerpt: Contracting laboratory revised their SOP for Analytical Method Validation/Verification.
View Details
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
Lupin Limited
21 Nov 2025 Normal Justification: Method validation directly affects result reliability and is compromised if initial validation is inadequate.
Excerpt: LC-MS/MS analytical test methods were validated ... observed sample test results of single batch were reported with variations.
View Details

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