FDA 483 - Intas Pharmaceuticals Ltd. - August 09, 2022

Intas Pharmaceuticals Ltd. in Moraiya, Ahmedabad, India, was cited for significant deficiencies across its drug substance and drug product manufacturing operations. The inspection revealed inadequate quality unit oversight, widespread data integrity issues in laboratory systems, and critical failures in aseptic technique and environmental monitoring. Additionally, the firm's cleaning and sanitization programs, equipment validation, and OOS investigations were found to be insufficient, indicating a systemic lack of control over GMP processes.