FDA 483 - Intas Pharmaceuticals Limited - December 07, 2023

During an inspection from November 30 to December 7, 2023, the FDA identified significant manufacturing and quality control deficiencies at Intas Pharmaceuticals Limited, a drug substance and drug product manufacturer located in Ahmedabad, Gujarat, India. The observations, detailed in an FDA 483, indicated a systemic failure to comply with Current Good Manufacturing Practices (CGMP) aimed at assuring drug product identity, strength, quality, and purity. Key issues included inadequate written procedures for production and process control, evidenced by numerous unresolved out-of-specification (OOS) investigations related to drug product degradation and contaminants. Laboratory controls were found deficient, with recurring testing failures lacking assignable causes and incomplete method validation procedures. Investigations into discrepancies and OOS results were scientifically unsound, often involving unjustified reanalysis and insufficient root cause analyses. The Quality Unit demonstrated inadequate oversight in managing GMP documents, ensuring complete batch records, and implementing effective corrective and preventive actions. Additionally, procedures to prevent microbiological contamination were lacking, and equipment qualification was found inadequate. Laboratory records exhibited deficiencies such as non-contemporaneous data entry, improper sample handling, and unvalidated analytical methods. Intas Pharmaceuticals Limited is required to thoroughly address these observations by revising procedures, conducting robust investigations, enhancing quality oversight, and implementing comprehensive corrective actions.