FDA 483 - Biokosmes Srl - December 02, 2022

An FDA inspection of Biokosmes Srl, an OTC drug manufacturer in Bosisio Parini, Italy, revealed significant deficiencies across multiple areas of its operations. The firm failed to ensure proper identity testing of components, lacked adequate controls for preventing microbial contamination, and operated with unsuitable facility conditions for raw material weighing. Additionally, issues were noted in batch record keeping, computer system security, laboratory controls, and the overall adherence to quality control unit procedures.