FDA 483 - Intas Pharmaceuticals Ltd. - December 07, 2023

Intas Pharmaceuticals Limited in Ahmedabad, India, received a Form 483 with seven observations during an inspection from November 30 to December 7, 2023. The inspection revealed significant deficiencies in quality control, including inadequate OOS investigations, poor laboratory controls, and failures in quality unit oversight. Additionally, issues with microbiological contamination prevention, equipment qualification, and laboratory record-keeping were noted, indicating a broad range of GMP non-compliance.