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Sub System /
Retain Samples
Retain Samples
View Detailed Analysis

Analytics Overview

26
Form 483s Issued
4
483s converted to WL
30
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
27 Mar 2026
Bentley Laboratories LLC
Drugs
View Form 483
27 Feb 2026
Gasco Industrial Corp.
Drugs
View Form 483
18 Feb 2026
Gilead Sciences, Inc.
Drugs
View Form 483
27 Jan 2026
Neeyaan LLC
Drugs
View Form 483
17 Dec 2025
Macau-Union Pharmaceutical Limited
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
6
0
Logan T Williams
4
1
Robert J Ham
3
0
Carolina D. Vanquez
2
0
Bryan L. Melnokn
2
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Bentley Laboratories LLC		 27 Mar 2026 Normal Justification: Retain sample assessments are crucial for comprehensive investigations and were neglected, violating SOP QA-034c.
Excerpt: Retain samples were not assessed in response to a Customer Concern Communication Report.
View Details
Reserve drug product samples are not appropriately identified, representative of each lot or batch of drug product and retained and stored under conditions consistent with product labeling.
Gasco Industrial Corp.		 27 Feb 2026 Normal Justification: This observation specifically points to issues with how reserve samples are handled, which is linked to Retain Samples process.
Excerpt: Reserve samples from representative sample lots or batches of drug products are not selected by acceptable statistical procedures and are not examined visually at least once a year for evidence of deterioration.
View Details
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
Gilead Sciences, Inc.		 18 Feb 2026 Normal Justification: The observation highlights a failure in the 'Retain Samples' process, as visual inspection of samples wasn't comprehensive.
Excerpt: visual inspection the (b) (4) vial for any evidence of product deterioration.
View Details
Reserve drug product samples are not representative of each lot or batch of drug product and retained and stored under conditions consistent with product labeling.
Gilead Sciences, Inc.		 18 Feb 2026 Normal Justification: Retain samples must reflect marketed product conditions as per SOP-08511; current non-compliance may affect integrity.
Excerpt: Reserve drug product samples are not representative...and stored under conditions consistent with product labeling.
View Details
Reserve samples from representative sample lots or batches of drug products are not examined visually at least once a year
Neeyaan LLC		 27 Jan 2026 Normal Justification: The SOP-46 shortcomings directly concern the Retain Samples process, evidenced by lapses in annual checks and logged storage.
Excerpt: Retain samples for OTC drug products are not inspected annually for evidence of deterioration and SOP-46 "Retain Samples" does not include requirements for conducting annual inspections.
View Details

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Retain Samples

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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Retain Samples

Overview

26
Form 483s Issued
4
483s converted to WL
30
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
27 Mar 2026
Bentley Laboratories LLC
Drugs
View Form 483
27 Feb 2026
Gasco Industrial Corp.
Drugs
View Form 483
18 Feb 2026
Gilead Sciences, Inc.
Drugs
View Form 483
27 Jan 2026
Neeyaan LLC
Drugs
View Form 483
17 Dec 2025
Macau-Union Pharmaceutical Limited
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
6
0
Logan T Williams
4
1
Robert J Ham
3
0
Carolina D. Vanquez
2
0
Bryan L. Melnokn
2
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Bentley Laboratories LLC		 27 Mar 2026 Normal Justification: Retain sample assessments are crucial for comprehensive investigations and were neglected, violating SOP QA-034c.
Excerpt: Retain samples were not assessed in response to a Customer Concern Communication Report.
View Details
Reserve drug product samples are not appropriately identified, representative of each lot or batch of drug product and retained and stored under conditions consistent with product labeling.
Gasco Industrial Corp.		 27 Feb 2026 Normal Justification: This observation specifically points to issues with how reserve samples are handled, which is linked to Retain Samples process.
Excerpt: Reserve samples from representative sample lots or batches of drug products are not selected by acceptable statistical procedures and are not examined visually at least once a year for evidence of deterioration.
View Details
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
Gilead Sciences, Inc.		 18 Feb 2026 Normal Justification: The observation highlights a failure in the 'Retain Samples' process, as visual inspection of samples wasn't comprehensive.
Excerpt: visual inspection the (b) (4) vial for any evidence of product deterioration.
View Details
Reserve drug product samples are not representative of each lot or batch of drug product and retained and stored under conditions consistent with product labeling.
Gilead Sciences, Inc.		 18 Feb 2026 Normal Justification: Retain samples must reflect marketed product conditions as per SOP-08511; current non-compliance may affect integrity.
Excerpt: Reserve drug product samples are not representative...and stored under conditions consistent with product labeling.
View Details
Reserve samples from representative sample lots or batches of drug products are not examined visually at least once a year
Neeyaan LLC		 27 Jan 2026 Normal Justification: The SOP-46 shortcomings directly concern the Retain Samples process, evidenced by lapses in annual checks and logged storage.
Excerpt: Retain samples for OTC drug products are not inspected annually for evidence of deterioration and SOP-46 "Retain Samples" does not include requirements for conducting annual inspections.
View Details

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