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Sub System /
Sample Testing
Sample Testing
View Detailed Analysis

Analytics Overview

81
Form 483s Issued
13
483s converted to WL
94
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
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
View Form 483
19 Dec 2025
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy
Drugs
View Form 483
12 Dec 2025
SMS Pharmaceuticals Limited, Unit-VII
Drugs
View Form 483
21 Nov 2025
Lupin Limited
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Kiya Hamilton
13
0
LaiMing Lee
13
0
David Carlson
13
0
Christy Osgood
13
0
Li Wang
13
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes.
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: Sample Testing processes failed due to uncertified kits affecting the validity of inspection procedures.
Excerpt: Your firm is currently performing inspection challenge tests using a separate challenge kit prepared in-house.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: Issues were directly linked with the handling and accuracy assurance of volumes during Sample Testing.
Excerpt: Lower volumes of lysate may decrease endotoxin test sensitivity and result in false negatives.
View Details
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to final specifications
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: The observation highlights deficiencies in testing procedures that directly align with Sample Testing, affecting product quality.
Excerpt: A demonstration of the firm’s destructive testing method was performed, and the visual operator was observed manually tapping the contents.
View Details
Established laboratory control mechanisms are not followed
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: A direct issue with Sample Testing as the OOS results arise from testing practices, necessitating revised procedural adherence.
Excerpt: Approximately 35% of the invalidations of OOS results were recorded...57% attributed to analyst error and 18% to equipment errors.
View Details
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy		 19 Dec 2025 Normal Justification: Sample Testing is crucial for verifying drug conformance to identity and strength; its absence directly impacts release procedures.
Excerpt: Your firm does not conduct routine testing for potency (assay) for all drug products produced by your firm.
View Details

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Sample Testing

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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Sample Testing

Overview

81
Form 483s Issued
13
483s converted to WL
94
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
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
View Form 483
19 Dec 2025
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy
Drugs
View Form 483
12 Dec 2025
SMS Pharmaceuticals Limited, Unit-VII
Drugs
View Form 483
21 Nov 2025
Lupin Limited
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Kiya Hamilton
13
0
LaiMing Lee
13
0
David Carlson
13
0
Christy Osgood
13
0
Li Wang
13
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes.
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: Sample Testing processes failed due to uncertified kits affecting the validity of inspection procedures.
Excerpt: Your firm is currently performing inspection challenge tests using a separate challenge kit prepared in-house.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: Issues were directly linked with the handling and accuracy assurance of volumes during Sample Testing.
Excerpt: Lower volumes of lysate may decrease endotoxin test sensitivity and result in false negatives.
View Details
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to final specifications
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: The observation highlights deficiencies in testing procedures that directly align with Sample Testing, affecting product quality.
Excerpt: A demonstration of the firm’s destructive testing method was performed, and the visual operator was observed manually tapping the contents.
View Details
Established laboratory control mechanisms are not followed
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: A direct issue with Sample Testing as the OOS results arise from testing practices, necessitating revised procedural adherence.
Excerpt: Approximately 35% of the invalidations of OOS results were recorded...57% attributed to analyst error and 18% to equipment errors.
View Details
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance
JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy		 19 Dec 2025 Normal Justification: Sample Testing is crucial for verifying drug conformance to identity and strength; its absence directly impacts release procedures.
Excerpt: Your firm does not conduct routine testing for potency (assay) for all drug products produced by your firm.
View Details

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