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Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| There is a failure to ensure that manufacturing processes are maintained in a validated state. Dr. Reddy's Laboratories Limited (Unit II) |
19 Nov 2024 | Normal | Justification: Failures in implementing CAPAs link to 'CAPA' as recurring issues are due to ineffective preventive actions. Excerpt: investigations do not always implement effective corrective and preventive actions to address the identified root causes View Details |
| There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch Granules India Limited |
06 Sep 2024 | Normal | Justification: The observation highlights that CAPA actions taken were insufficient in determining risk, necessitating a review. Excerpt: the CAPA taken is inadequate to determine the risk to the drug products sold into the US market. View Details |
| There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. Granules India Limited |
06 Sep 2024 | Normal | Justification: The observation highlights that CAPA procedures were not effective. Excerpt: the CAPA taken is inadequate to determine the risk to the drug products sold into the US market. View Details |
| There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications. Granules India Limited |
06 Sep 2024 | Normal | Justification: Observation mentions inadequate CAPA which directly ties to the CAPA process deficiencies. Excerpt: CAPA taken is inadequate to determine the risk to the drug products sold into the US market. View Details |
| Your firm failed to thoroughly investigate any unexplained discrepancy or failure Zydus Lifesciences Limited |
29 Aug 2024 | Normal | Justification: The repeated occurrence of contamination indicates ineffective CAPA implementation. Excerpt: Your firm attempted to implement improved cleaning as a corrective action and preventive action (CAPA) but continued to manufacture and identify cross-contamination. View Details |
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