FDA 483 - Aurore Pharmaceuticals Private Limited (Unit I) - May 31, 2024

An FDA inspection conducted from May 27-31, 2024, at Aurore Pharmaceutical Pvt Ltd in Hyderabad, India, identified significant observations related to the manufacturing of Active Pharmaceutical Ingredients (APIs). The inspection, documented in an FDA Form 483, highlighted several areas requiring immediate attention to ensure compliance with quality standards.Key violations included the failure to adequately clean and maintain equipment, with inspectors noting residue, scratches, pits, and rust-like material on product contact surfaces, along with a lack of air sampling in critical manufacturing areas. Furthermore, the firm was cited for not establishing adequate written procedures for production and process controls. This included missing critical process parameters for final APIs, inadequate corrective actions for recurrent low yield deviations, and insufficient impurity profile comparisons for process changes. Investigations into product failures were found to be incomplete, lacking thorough data review and root cause identification for unknown impurities. The facility itself showed poor maintenance, with cracked cleanroom floors, leaking sinks, standing water, and improper product storage. Finally, the quality control unit failed to uphold its responsibilities, demonstrated by delayed stability studies and errors in Annual Product Quality Reviews. Aurore Pharmaceutical Pvt Ltd is required to address these observations comprehensively by implementing robust corrective and preventive actions to ensure the identity, strength, purity, and quality of its APIs.