FDA 483 - Intas Pharmaceuticals Ltd. - January 24, 2024

An FDA inspection of Intas Pharmaceuticals Limited in Dehradun, India, revealed significant deficiencies in quality control, aseptic processing, and laboratory practices. The firm failed to conduct adequate investigations into out-of-specification results and market complaints, maintain proper environmental monitoring, and ensure the integrity of its sterile manufacturing processes. These findings indicate a lack of robust quality systems and adherence to established procedures.