483
Centaur Pharmaceuticals Private Ltd.FDA 483 - Centaur Pharmaceuticals Private Ltd. - November 21, 2022
Record Details
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.
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ID · 4a591dbb-e749-4fd1-9802-57abaa2496e6