FDA EIR - American Regent, Inc. - January 08, 2020

An FDA inspection of American Regent, Inc.'s control testing laboratory in Columbus, Ohio, was conducted from January 6-8, 2020. This preapproval and GMP inspection, covering human and animal drug testing, evaluated the firm's readiness for commercial manufacturing, application conformance, and data integrity under relevant regulatory guidelines. While no official FDA-483 observations were issued, three significant discussion items were raised with management. Firstly, a laboratory workstation permitted a user-level account to alter the operating system's date and time, posing a data integrity risk to associated software. Secondly, a written procedure for assaying Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension contained ambiguous instructions for establishing system suitability, which could lead to incorrect analytical sequences. Lastly, an operator was observed making physical contact with sanitized equipment surfaces during aseptic preparation, indicating a potential lapse in maintaining sterile conditions. American Regent's management acknowledged these findings, initiating immediate corrections for the workstation's date/time control and promptly starting deviations and change controls to update affected procedures. Investigations were also initiated for all identified issues. The inspection concluded without formal observations, with management demonstrating cooperation throughout the process.