FDA 483 - Centaur Pharmaceuticals Private Ltd. - November 21, 2022

An FDA inspection of Centaur Pharmaceuticals Private Ltd. in Ambernath, India, revealed severe data integrity issues, including the destruction of original GMP documents, widespread inaccurate and non-contemporaneous record-keeping, and a lack of electronic data controls. The firm also demonstrated significant deficiencies in OOS investigations, facility and equipment maintenance, analytical method validation, and overall quality unit oversight. These findings indicate a critical breakdown in the company's quality management system.