FDA 483 - BDR Pharmaceuticals International Private, Ltd. - November 20, 2025

The FDA conducted an inspection of BDR Pharmaceuticals International Private, Ltd., a sterile drug manufacturer in Halol, Gujarat, India, from November 11 to November 20, 2025. This inspection resulted in a Form FDA 483 with four observations, indicating significant deviations from current Good Manufacturing Practices (cGMP) essential for drug product quality and sterility. Key issues included a failure to establish and follow procedures to prevent microbiological contamination, evidenced by disrupted unidirectional airflow in the aseptic filling area during a smoke study. Laboratory controls were also found deficient, particularly in the personnel monitoring program, which lacked clear sampling details and consistent application of Grade A specifications for personnel performing aseptic interventions. Equipment maintenance in aseptic processing areas was inadequate, with observations of missing bolts, excessive sealant, and discoloration that could compromise sterility. Additionally, the facility's building construction was deemed unsuitable for proper operations, as the aseptic vial filling area lacked adequate visibility from the viewing window, hindering effective observation of critical interventions. BDR Pharmaceuticals is required to implement comprehensive corrective actions to address these findings and ensure compliance with regulatory standards.