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Sub System /
Retain Samples
Retain Samples
View Detailed Analysis

Analytics Overview

13
Form 483s Issued
3
483s converted to WL
16
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
17 Feb 2025
Piramal Pharma Limited
Drugs
View Form 483
15 Nov 2024
Exela Pharma Sciences LLC
Drugs
View Form 483
27 Sep 2024
RC Outsourcing, LLC
Drugs
View Form 483
28 Jun 2024
Fagron Compounding Services, LLC dba Fagron Sterile Services
Drugs
View Form 483
View Warning Letter
27 Mar 2024
Alkem Laboratories Limited
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Robert J Ham
3
0
Logan T Williams
3
0
Clifton L Randell
2
2
Jamie L Port
2
2
June P Page
2
2

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Written records of investigation of an API complaint do not include adequate follow-up
Piramal Pharma Limited		 17 Feb 2025 Normal Justification: The observation indicates a failure to appropriately test retained samples in response to a complaint, linking directly to the 'Retain Samples' process.
Excerpt: Retention samples of the sample batch were not tested... there was no documented reasoning as to how the control sample size necessary to conduct the complaint investigation was determined.
View Details
Established laboratory control mechanisms are not followed and documented at the time of performance
Exela Pharma Sciences LLC		 15 Nov 2024 Normal Justification: Retain sample storage directly relates to this observation as improper storage and documentation led to sample misplacement.
Excerpt: Retain samples for commercial products and raw materials were not stored in their designated locations as required by SOP-000024.
View Details
Reserve drug product samples are not appropriately identified and representative of each lot or batch of drug product.
RC Outsourcing, LLC		 27 Sep 2024 Normal Justification: Lack of procedures for retention samples led to unavailability during investigations.
Excerpt: Your firm does not maintain retention samples for any finished product batches.
View Details
Complaint records are deficient in that they do not include the findings of the investigation and follow- up.
Fagron Compounding Services, LLC dba Fagron Sterile Services		 28 Jun 2024 Normal Justification: Retention samples should be used to verify the quality and sterility of produced batches, especially when specific complaints are raised.
Excerpt: No sterility tests were performed on retention samples from the batches related to these adverse event reports.
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
Alkem Laboratories Limited		 27 Mar 2024 Normal Justification: The observation explicitly mentions the lack of visual examination of retain samples, directly linking the issue to the 'Retain Samples' process type.
Excerpt: No annual visual examination has been performed for the control samples... Firm personnel stated they started collecting observation sample for each batch in February 2024 and will conduct the first review of those samples in one year.
View Details

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Go back

Retain Samples

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

Retain Samples

Overview

13
Form 483s Issued
3
483s converted to WL
16
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
17 Feb 2025
Piramal Pharma Limited
Drugs
View Form 483
15 Nov 2024
Exela Pharma Sciences LLC
Drugs
View Form 483
27 Sep 2024
RC Outsourcing, LLC
Drugs
View Form 483
28 Jun 2024
Fagron Compounding Services, LLC dba Fagron Sterile Services
Drugs
View Form 483
View Warning Letter
27 Mar 2024
Alkem Laboratories Limited
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Robert J Ham
3
0
Logan T Williams
3
0
Clifton L Randell
2
2
Jamie L Port
2
2
June P Page
2
2

Key Observations

TITLE/ COMPANY Issue Date Status Details
Written records of investigation of an API complaint do not include adequate follow-up
Piramal Pharma Limited		 17 Feb 2025 Normal Justification: The observation indicates a failure to appropriately test retained samples in response to a complaint, linking directly to the 'Retain Samples' process.
Excerpt: Retention samples of the sample batch were not tested... there was no documented reasoning as to how the control sample size necessary to conduct the complaint investigation was determined.
View Details
Established laboratory control mechanisms are not followed and documented at the time of performance
Exela Pharma Sciences LLC		 15 Nov 2024 Normal Justification: Retain sample storage directly relates to this observation as improper storage and documentation led to sample misplacement.
Excerpt: Retain samples for commercial products and raw materials were not stored in their designated locations as required by SOP-000024.
View Details
Reserve drug product samples are not appropriately identified and representative of each lot or batch of drug product.
RC Outsourcing, LLC		 27 Sep 2024 Normal Justification: Lack of procedures for retention samples led to unavailability during investigations.
Excerpt: Your firm does not maintain retention samples for any finished product batches.
View Details
Complaint records are deficient in that they do not include the findings of the investigation and follow- up.
Fagron Compounding Services, LLC dba Fagron Sterile Services		 28 Jun 2024 Normal Justification: Retention samples should be used to verify the quality and sterility of produced batches, especially when specific complaints are raised.
Excerpt: No sterility tests were performed on retention samples from the batches related to these adverse event reports.
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
Alkem Laboratories Limited		 27 Mar 2024 Normal Justification: The observation explicitly mentions the lack of visual examination of retain samples, directly linking the issue to the 'Retain Samples' process type.
Excerpt: No annual visual examination has been performed for the control samples... Firm personnel stated they started collecting observation sample for each batch in February 2024 and will conduct the first review of those samples in one year.
View Details

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