FDA 483 - Pharmathen International S.A. - March 09, 2022

An FDA inspection of Pharmathen International S.A., a drug manufacturer in Rodopi, Greece, revealed significant deficiencies in aseptic processing, laboratory controls, and quality control unit procedures. The firm failed to ensure proper disinfectant contact times, lacked adequate testing for visible particulates in injectable products, and did not perform periodic audit trail reviews of electronic data.