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Retain Samples
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | 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 |
| Evidence of reserve drug product sample deterioration was not investigated Eugia US Manufacturing LLC |
22 Dec 2023 | Normal | Justification: The observation directly mentions the deterioration of retain samples and the lack of documentation of investigations into these discrepancies, aligning with the 'Retain Samples' process type. Excerpt: Evidence of reserve drug product sample deterioration was not investigated....retain samples...demonstrated deterioration...Your firm does not have any documentation of investigation into these discrepancies. 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. Sun Pharmaceutical Industries Limited |
15 Dec 2023 | Normal | Justification: The observation directly relates to improper handling and examination of retain samples, which are crucial for detecting product defects before they reach consumers. Excerpt: Specifically, A) Each lot of Controlled/Reserve (Retain) samples of drug products is not examined at least once a year for the evidence of deterioration and physical defects. View Details |
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