FDA 483 - Sun Pharmaceutical Medicare Limited - February 05, 2019

The FDA conducted an inspection of Sun Pharmaceutical Medicare Limited's facility in Ujeti, Baska, Panchmahal, from January 28 to February 5, 2019. This inspection resulted in an FDA Form 483 observation, indicating potential deviations from current good manufacturing practices. The primary issue identified was the company's failure to thoroughly investigate unexplained discrepancies and out-of-specification (OOS) results, particularly concerning product quality tests. Specifically, the FDA observed that Sun Pharmaceutical Medicare Limited repeatedly invalidated OOS results obtained during re-dispersibility tests for various products. These invalidations were consistently attributed to "human error," citing inadequate sample shaking by analysts during preparation, without sufficient supporting evidence. The report noted that analysts involved in these tests had received training in sample preparation. Instead of conducting comprehensive investigations, the firm often performed re-tests with a different analyst, reporting passing average results. This observation highlights a critical deficiency in the company's quality control procedures, indicating a lack of robust root cause analysis when product tests fail to meet specifications. To address this, Sun Pharmaceutical Medicare Limited is required to implement comprehensive corrective and preventive actions. These actions must ensure that all OOS results are thoroughly reviewed, investigated with adequate scientific evidence, and that root causes are properly identified and addressed to maintain product quality and regulatory compliance.