FDA 483 - Accugen Laboratories, Inc. - April 22, 2022

An FDA inspection of Accugen Laboratories, Inc. in Addison, IL, a contract laboratory, revealed significant deficiencies in laboratory controls and record-keeping. The firm failed to demonstrate the suitability of its USP71-Sterility Test method and lacked a proper quality agreement with its sponsor. Additionally, laboratory records were found to be incomplete, missing analyst initials, dates, and clear time notations.