FDA 483 - Concord Biotech Limited - May 02, 2025

An FDA inspection conducted at Concord Biotech Limited, an Active Pharmaceutical Ingredient (API) manufacturer located in Dholka Ahmedabad, Gujarat, India, from April 28 to May 2, 2025, revealed significant deviations from current Good Manufacturing Practices (GMP). The U.S. Food and Drug Administration issued a Form FDA 483 detailing four primary observations. The inspection noted a failure in equipment cleaning, with residues and particles found on manufacturing equipment (specifically a reactor) despite documented cleaning, raising concerns about product contamination and quality. Laboratory controls were found deficient as microbiological test results for finished API release, including Total Aerobic Microbial Count and Total Yeast and Mold Count, were not verified by a second qualified individual, and the relevant Standard Operating Procedure lacked this critical requirement. Furthermore, the company demonstrated inadequate controls over computerized systems, impacting data integrity. This included the use of common usernames ("operator" for electronic balances and "CBL\qa" for batch record issuance) allowing unauthorized access and a lack of quality unit review for electronic data. Lastly, the FDA observed a critical failure to monitor and control water quality used in manufacturing an API intended for a sterile drug product. Specifically, water utilized in sensitive manufacturing steps was not tested for total microbial counts or endotoxins, posing a risk to the sterility of the final drug product. Concord Biotech Limited is required to address these observations by implementing comprehensive corrective and preventive actions to ensure compliance with regulatory standards for API manufacturing.