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

An FDA inspection of Pharmathen International S.A. in Rodopi, Greece, revealed significant deficiencies in their manufacturing operations. Observations included inadequate cleaning and disinfection procedures for aseptic processing areas, insufficient laboratory controls for inspecting drug products for particulates, and a failure of the Quality Assurance unit to perform periodic audit trail reviews of electronic data. These issues suggest a lack of robust quality systems to ensure product sterility, quality, and data integrity.