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Complaint Management
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| Investigations into product complaints are inadequate to ensure complaint investigations identify appropriate root causes, assess potential product impact, and implement scientific sound sustainable corrective action and preventive action. Dr. Reddy's Laboratories Limited (Unit II) |
19 Nov 2024 | Normal | Justification: The issue revolves around inadequate complaint management practices, specifically in investigating and resolving customer feedback effectively. Excerpt: You received a customer complaint #200407887 on 12/20/2022 from US customer for (b) (4) USP (b) (4) which identified the API you supplied (Batch # (b) (4) manufactured on 03/07/2022) showed OOS for Particle Size Distribution... View Details |
| Complaint procedures are deficient in that they do not include provisions that allow for the review and determination of an investigation by the quality control unit. RC Outsourcing, LLC |
27 Sep 2024 | Normal | Justification: The observation directly pertains to Complaint Management as it highlights deficiencies in handling and investigating customer complaints. Excerpt: Complaint procedures are deficient in that they do not include provisions that allow for the review and determination of an investigation. 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: Complaints investigation was hindered due to lack of supporting retention samples. Excerpt: Five complaints of endophthalmitis; no samples available for further examination. View Details |
| There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch Nephron Sterile Compounding Center LLC |
25 Sep 2024 | Normal | Justification: Complaints about odors in BFS lots were not properly investigated leading to unresolved customer dissatisfaction. Excerpt: The complaint vials were thrown away without further investigatory action. View Details |
| Written procedures is not established and followed for investigating critical deviations or the failure of a batch Aarti Drugs Limited |
20 Sep 2024 | Normal | Justification: The occurrence of a market complaint highlights deficiencies in complaint management systems. Excerpt: you received a market complaint CPL/22005 for the presence of foreign particle. View Details |
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