FDA 483 - Alcami Carolinas Corporation - March 28, 2017

During an inspection, Alcami Corporation, a contract testing laboratory in Affton, MO, was cited for two significant issues. Inspectors found that USP reference standards were improperly stored at room temperature instead of in a refrigerator, indicating a failure in laboratory control mechanisms. Additionally, the firm lacked appropriate controls over computer systems, as analysts could freely change time and date settings on critical laboratory equipment, raising concerns about data integrity.