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Quality Risk Management
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| The responsibilities and procedures applicable to the quality control unit are not in writing or fully followed Dr. Reddy's Laboratories Limited (Unit II) |
19 Nov 2024 | Normal | Justification: Observation B highlights operator non-compliance to GMP, affecting quality risk through potential contamination. Excerpt: Observed an operator with exposed hair over the Stage/Intermediate drum, indicating a breach in GMP. View Details |
| The responsibilities and procedures applicable to the quality control unit are not in writing OSRX Inc. |
25 Oct 2024 | Normal | Justification: The observation highlights the inadequacy in defining responsibilities related to risk management and QC processes. Excerpt: The responsibilities and procedures applicable to the quality control unit are not in writing. View Details |
| Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and written. Nephron Sterile Compounding Center LLC |
25 Sep 2024 | Normal | Justification: Handling and risk evaluation of objectionable organisms fall under Quality Risk Management. Excerpt: No risk assessment has been performed to determine the potential for objectionable eukaryotic organisms and the impact they may have. View Details |
| Your internal audit is not effective to verify compliance with the principles of CGMP for APIs. Aarti Drugs Limited |
20 Sep 2024 | Normal | Justification: Quality Risk Management is linked due to the observation on undefined procedures in QA vigilance affecting risk assessments. Excerpt: Neither of these quality activities; the vigilance reports, or the trending, have an establish written procedures. View Details |
| The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. Granules India Limited |
06 Sep 2024 | Normal | Justification: The failure to manage GMP documents properly poses a quality risk, underlining the need for enhanced Quality Risk Management practices. Excerpt: The inspection revealed a large number of torn pieces of GMP documents, highlighting poor risk management. View Details |
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