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Sub System /
Method Validation
Method Validation
View Detailed Analysis

Analytics Overview

76
Form 483s Issued
12
483s converted to WL
90
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
18 Aug 2026
Imprimis NJOF, LLC
Drugs
20 May 2026
Strides Pharma Science Ltd.
Drugs
27 Mar 2026
Allure Labs, LLC
Drugs
27 Mar 2026
Bentley Laboratories LLC
Drugs
27 Mar 2026
Fujifilm Diosynth Biotechnologies USA Inc.
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
9
3
Pratik S Upadhyay
5
0
Ruben C. Ayala, PharmD, Lead Pharmacokineticist
4
0
Justin A Boyd
4
1
Saleem A Akhtar
4
1
TITLE/ COMPANY Issue Date Status Details
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications...
Imprimis NJOF, LLC
18 Aug 2026 Normal Justification: The observation highlights a critical lack of validated impurity detection methods, central to Method Validation.
Excerpt: Your firm has not completed and implemented method validation for impurities and degradants for thirty-three...
View Details
Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards
Strides Pharma Science Ltd.
20 May 2026 Normal Justification: The core issue arises from using unvalidated methods in microbial limit testing and identification, requiring method validation.
Excerpt: Your microbiological identification method used for confirmatory identification of microorganisms has not been validated or verified for its intended use.
View Details
The suitability of all testing methods is not verified under actual conditions of use.
Bentley Laboratories LLC
27 Mar 2026 Normal Justification: Method validation is directly linked with verifying the applicability of testing methods under actual conditions of use.
Excerpt: Failure to ensure that the approved contract laboratory has performed method suitability of compendial methods...
View Details
You have not ensured your microbiological methods are suitable for your operations.
Fujifilm Diosynth Biotechnologies USA Inc.
27 Mar 2026 Normal Justification: Method Validation is crucial to ensuring microbiological tests detect all relevant organisms and meet quality standards.
Excerpt: You have not performed a risk assessment or evaluation to determine if your current bioburden methods of testing ... is suitable...
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 observation highlights the absence of method validation, which directly relates to 'Method Validation'.
Excerpt: Failure to ensure that the approved contract laboratory has performed validation of the in-house method for Assay tests.
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

76
Form 483s Issued
12
483s converted to WL
90
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
18 Aug 2026
Imprimis NJOF, LLC
Drugs
20 May 2026
Strides Pharma Science Ltd.
Drugs
27 Mar 2026
Allure Labs, LLC
Drugs
27 Mar 2026
Bentley Laboratories LLC
Drugs
27 Mar 2026
Fujifilm Diosynth Biotechnologies USA Inc.
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
9
3
Pratik S Upadhyay
5
0
Ruben C. Ayala, PharmD, Lead Pharmacokineticist
4
0
Justin A Boyd
4
1
Saleem A Akhtar
4
1

Key Observations

TITLE/ COMPANY Issue Date Status Details
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications...
Imprimis NJOF, LLC
18 Aug 2026 Normal Justification: The observation highlights a critical lack of validated impurity detection methods, central to Method Validation.
Excerpt: Your firm has not completed and implemented method validation for impurities and degradants for thirty-three...
View Details
Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards
Strides Pharma Science Ltd.
20 May 2026 Normal Justification: The core issue arises from using unvalidated methods in microbial limit testing and identification, requiring method validation.
Excerpt: Your microbiological identification method used for confirmatory identification of microorganisms has not been validated or verified for its intended use.
View Details
The suitability of all testing methods is not verified under actual conditions of use.
Bentley Laboratories LLC
27 Mar 2026 Normal Justification: Method validation is directly linked with verifying the applicability of testing methods under actual conditions of use.
Excerpt: Failure to ensure that the approved contract laboratory has performed method suitability of compendial methods...
View Details
You have not ensured your microbiological methods are suitable for your operations.
Fujifilm Diosynth Biotechnologies USA Inc.
27 Mar 2026 Normal Justification: Method Validation is crucial to ensuring microbiological tests detect all relevant organisms and meet quality standards.
Excerpt: You have not performed a risk assessment or evaluation to determine if your current bioburden methods of testing ... is suitable...
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 observation highlights the absence of method validation, which directly relates to 'Method Validation'.
Excerpt: Failure to ensure that the approved contract laboratory has performed validation of the in-house method for Assay tests.
View Details

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