FDA 483 - MF Productions Saumur - September 15, 2023

During an inspection of MF Productions Saumur, a contract manufacturer in Bellevigne-Les-Chateaux, France, the FDA observed a significant issue regarding data integrity and access controls. The firm failed to implement appropriate controls over computer systems, specifically Empower 3 software used for HPLC data, to ensure changes are made only by authorized personnel. This included the use of common usernames and passwords for QA and QC managers with administrator privileges, violating individual identity verification requirements.