FDA 483 - Nesher Pharmaceuticals (USA) LLC - May 31, 2019

An FDA inspection of Nesher Pharmaceuticals (USA) LLC in Maryland Heights, MO, revealed significant deficiencies in computer system controls, equipment cleaning, and personnel hygiene. The firm failed to ensure only authorized personnel made changes to records, did not follow written procedures for equipment maintenance, and lacked proper sanitation practices for production staff. These observations indicate a lack of adherence to good manufacturing practices.