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Sub System /
Sample Testing
Sample Testing
View Detailed Analysis

Analytics Overview

120
Form 483s Issued
13
483s converted to WL
132
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
16 Sep 2025
Fareva Amboise
Drugs
View Form 483
05 Sep 2025
FARMAKEIO OUTSOURCING LLC
Drugs
View Form 483
12 Aug 2025
Cohance Lifesciences Limited
Drugs
View Form 483
18 Jul 2025
Dr. Reddy's Laboratories Limited , FTO-11
Drugs
View Form 483
18 Jul 2025
GenoGenix, LLC
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Jane Smith
40
0
John Doe
40
0
José E Melendez
9
3
John Smith
8
0
Jane Doe
6
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
Fareva Amboise		 16 Sep 2025 Normal Justification: Sample testing, particularly visual inspection, is critical for detecting and preventing defective products from reaching the market.
Excerpt: Challenge tests sets used to qualify visual inspectors have not been designed to thoroughly challenge the visual inspectors.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures
FARMAKEIO OUTSOURCING LLC		 05 Sep 2025 Normal Justification: Metal detection testing was non-compliant due to inadequate sample size.
Excerpt: Failed to comply with USP <790>, allowing AQL for batch release inspection.
View Details
Each batch of controlled-release dosage form drug product is not laboratory tested to determine conformance to the specifications
FARMAKEIO OUTSOURCING LLC		 05 Sep 2025 Normal Justification: The issue relates directly to testing the release rate of active ingredients, indicating a sample testing deficiency.
Excerpt: Your firm failed to require or perform dissolution testing on each batch of controlled-release dosage form drug product.
View Details
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications
Cohance Lifesciences Limited		 12 Aug 2025 Normal Justification: Sample testing inaccuracies directly affect the reliability of quality data and decision-making.
Excerpt: Proposed to collect the content and assay samples at stage in vials to eliminate error during weighing.
View Details
Testing and release of drug product for distribution
Dr. Reddy's Laboratories Limited , FTO-11		 18 Jul 2025 Normal Justification: Sample Testing is directly connected as improper testing resulted in undetected particulates.
Excerpt: does not provide adequate contrast required to ensure that particles... can be visually detected.
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

120
Form 483s Issued
13
483s converted to WL
132
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
16 Sep 2025
Fareva Amboise
Drugs
View Form 483
05 Sep 2025
FARMAKEIO OUTSOURCING LLC
Drugs
View Form 483
12 Aug 2025
Cohance Lifesciences Limited
Drugs
View Form 483
18 Jul 2025
Dr. Reddy's Laboratories Limited , FTO-11
Drugs
View Form 483
18 Jul 2025
GenoGenix, LLC
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Jane Smith
40
0
John Doe
40
0
José E Melendez
9
3
John Smith
8
0
Jane Doe
6
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
Fareva Amboise		 16 Sep 2025 Normal Justification: Sample testing, particularly visual inspection, is critical for detecting and preventing defective products from reaching the market.
Excerpt: Challenge tests sets used to qualify visual inspectors have not been designed to thoroughly challenge the visual inspectors.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures
FARMAKEIO OUTSOURCING LLC		 05 Sep 2025 Normal Justification: Metal detection testing was non-compliant due to inadequate sample size.
Excerpt: Failed to comply with USP <790>, allowing AQL for batch release inspection.
View Details
Each batch of controlled-release dosage form drug product is not laboratory tested to determine conformance to the specifications
FARMAKEIO OUTSOURCING LLC		 05 Sep 2025 Normal Justification: The issue relates directly to testing the release rate of active ingredients, indicating a sample testing deficiency.
Excerpt: Your firm failed to require or perform dissolution testing on each batch of controlled-release dosage form drug product.
View Details
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications
Cohance Lifesciences Limited		 12 Aug 2025 Normal Justification: Sample testing inaccuracies directly affect the reliability of quality data and decision-making.
Excerpt: Proposed to collect the content and assay samples at stage in vials to eliminate error during weighing.
View Details
Testing and release of drug product for distribution
Dr. Reddy's Laboratories Limited , FTO-11		 18 Jul 2025 Normal Justification: Sample Testing is directly connected as improper testing resulted in undetected particulates.
Excerpt: does not provide adequate contrast required to ensure that particles... can be visually detected.
View Details

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