FDA 483 - Intas Pharmaceuticals Ltd. - May 10, 2017

On May 10, 2017, an FDA inspection at Intas Pharmaceuticals Ltd. in Moraiya, India, resulted in a Form 483 with multiple observations concerning deviations from Current Good Manufacturing Practice (CGMP) regulations.

The inspection revealed significant issues with the facility's quality control and manufacturing processes. A key observation was the failure to thoroughly investigate unexplained discrepancies and the failure of a batch or its components to meet specifications. Specifically, the firm did not adequately investigate out-of-specification (OOS) results for impurities found in multiple batches of an active pharmaceutical ingredient (API), Valsartan. The investigation into these OOS results was deemed insufficient, lacking a comprehensive root cause analysis and effective corrective and preventive actions (CAPA).

Furthermore, the firm's quality control unit was cited for not exercising its responsibilities to ensure that drug products manufactured at the facility met the identity, strength, quality, and purity characteristics they purported to possess. This included a lack of adequate oversight on laboratory controls and data integrity. The observations indicate a systemic issue with the firm's quality management system, particularly in handling deviations and OOS results, which could impact the quality and safety of their drug products.