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Deviations
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components OSRX Inc. |
25 Oct 2024 | Normal | Justification: The failure to investigate quality events and inspection failures highlights lapses in deviation handling. Excerpt: Your firm failed to thoroughly investigation quality events that had environmental monitoring recoveries that exceeded specification limits. 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 observation cited the absence of written procedures for investigating critical deviations Excerpt: Written procedures is not established and followed for investigating critical deviations. View Details |
| Responsibilities and procedures for quality units are not in writing and/or followed to ensure the API and intermediates manufactured... Aarti Drugs Limited |
20 Sep 2024 | Normal | Justification: The observation highlights failure in managing deviations, with missing action plans and ineffective solutions for deviation reports. Excerpt: Your firm failed to provide a comprehensive assessment and remediation plan for your deviation reports DEV-24004, DEV24001 and DEV-24002... View Details |
| There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch Annovex Pharma, Inc. |
06 Sep 2024 | Normal | Justification: Deviations process is linked as it's crucial for addressing and resolving batch discrepancies. Excerpt: There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch. View Details |
| Written procedures are not followed that describe the in-process controls Granules India Limited |
06 Sep 2024 | Normal | Justification: Failure to follow deviation protocols related to testing results indicates gaps in deviation management processes. Excerpt: A deviation is to be opened in the event of a parameter found out of the specified limit given. View Details |
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