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Sub System /
Method Validation
Method Validation
View Detailed Analysis

Analytics Overview

42
Form 483s Issued
9
483s converted to WL
46
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
13 Jun 2025
Sun Pharmaceutical Industries Ltd.
Drugs
View Form 483
23 May 2025
Stokes Healthcare Inc. dba Epicur Pharma
Drugs
View Form 483
10 Apr 2025
Aurolige Pharma LLC
Drugs
View Form 483
04 Apr 2025
QuVa Pharma, Inc.
Drugs
View Form 483
14 Feb 2025
Glenmark Pharmaceuticals Ltd
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Pratik S Upadhyay
6
1
Justin A Boyd
6
2
Joanne E King
3
1
Christina K Theodorou
3
0
Arsen Karapetyan
3
1

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures
Sun Pharmaceutical Industries Ltd.		 13 Jun 2025 Normal Justification: Method validation is directly linked as the observation highlights inadequate scientific method transfer affecting testing reliability.
Excerpt: There is no variable involved in analysis conducted by both the Analysts to ensure transfer of method is accurate and reliable.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures
Stokes Healthcare Inc. dba Epicur Pharma		 23 May 2025 Normal Justification: Method Validation is crucial in ensuring that analytical test methods produce reliable and reproducible results.
Excerpt: The method for impurity testing - Draft Test Method: Assay of Impurities in Tacrolimus AQ Ophthalmic Suspension by UPLC - has not yet been validated.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
Aurolige Pharma LLC		 10 Apr 2025 Normal Justification: The issue directly links to the validation process as the method was not scientifically sound and lacked thorough validation procedures.
Excerpt: Your firm failed to establish a scientifically sound method to test related substances in Drug Substance.
View Details
The accuracy, specificity and reproducibility of test methods have not been established.
QuVa Pharma, Inc.		 04 Apr 2025 Normal Justification: Method Validation is critical, as the observation highlights issues with qualifying sterility testing methods specific to recovery percentages.
Excerpt: Your firm did not appropriately qualify the performance qualification, RDIReport-0083, for sterility testing method.
View Details
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
Glenmark Pharmaceuticals Ltd		 14 Feb 2025 Normal Justification: Method Validation is directly impacted, as inadequate validation or verification can render analytical results unreliable, leading to potential compliance risks.
Excerpt: Commercial drug products and API test methods, including in-house and compendial test methods, were not validated or verified appropriately.
View Details

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Go back

Method Validation

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

Method Validation

Overview

42
Form 483s Issued
9
483s converted to WL
46
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
13 Jun 2025
Sun Pharmaceutical Industries Ltd.
Drugs
View Form 483
23 May 2025
Stokes Healthcare Inc. dba Epicur Pharma
Drugs
View Form 483
10 Apr 2025
Aurolige Pharma LLC
Drugs
View Form 483
04 Apr 2025
QuVa Pharma, Inc.
Drugs
View Form 483
14 Feb 2025
Glenmark Pharmaceuticals Ltd
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Pratik S Upadhyay
6
1
Justin A Boyd
6
2
Joanne E King
3
1
Christina K Theodorou
3
0
Arsen Karapetyan
3
1

Key Observations

TITLE/ COMPANY Issue Date Status Details
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures
Sun Pharmaceutical Industries Ltd.		 13 Jun 2025 Normal Justification: Method validation is directly linked as the observation highlights inadequate scientific method transfer affecting testing reliability.
Excerpt: There is no variable involved in analysis conducted by both the Analysts to ensure transfer of method is accurate and reliable.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures
Stokes Healthcare Inc. dba Epicur Pharma		 23 May 2025 Normal Justification: Method Validation is crucial in ensuring that analytical test methods produce reliable and reproducible results.
Excerpt: The method for impurity testing - Draft Test Method: Assay of Impurities in Tacrolimus AQ Ophthalmic Suspension by UPLC - has not yet been validated.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
Aurolige Pharma LLC		 10 Apr 2025 Normal Justification: The issue directly links to the validation process as the method was not scientifically sound and lacked thorough validation procedures.
Excerpt: Your firm failed to establish a scientifically sound method to test related substances in Drug Substance.
View Details
The accuracy, specificity and reproducibility of test methods have not been established.
QuVa Pharma, Inc.		 04 Apr 2025 Normal Justification: Method Validation is critical, as the observation highlights issues with qualifying sterility testing methods specific to recovery percentages.
Excerpt: Your firm did not appropriately qualify the performance qualification, RDIReport-0083, for sterility testing method.
View Details
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
Glenmark Pharmaceuticals Ltd		 14 Feb 2025 Normal Justification: Method Validation is directly impacted, as inadequate validation or verification can render analytical results unreliable, leading to potential compliance risks.
Excerpt: Commercial drug products and API test methods, including in-house and compendial test methods, were not validated or verified appropriately.
View Details

Frequently Asked Questions

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