FDA EIR - Alcami Carolinas Corporation - January 16, 2020

An FDA inspection was conducted at Alcami Corporation in Saint Louis, MO, from January 14-16, 2020. This comprehensive surveillance inspection covered the company's operations as a contract testing laboratory for human and veterinary drug products. The inspection adhered to Good Manufacturing Practices (GMP) for both human and animal drug manufacturing, guided by relevant compliance programs. A notable finding was that no FDA 483, Inspectional Observations, was issued at the conclusion of the current inspection, indicating general adherence to regulatory standards. However, a key discussion point with management involved the identification of employees with multiple user roles within the laboratory information system. Investigators raised concerns that, without strict controls, such configurations could potentially lead to data manipulation. Management acknowledged these concerns and their ongoing responsibility to maintain full compliance with the Federal Food, Drug, and Cosmetic Act. The report also highlighted successful voluntary corrections to prior observations from a 2017 inspection, specifically regarding the proper storage of USP reference standards and restricted access to time and date settings on laboratory equipment, improving overall data integrity.