FDA 483 - NerPharMa S.r.l. - June 19, 2024

An FDA inspection of NerPharMa S.r.l. in Nerviano, Milan, revealed significant deficiencies across multiple areas of drug manufacturing. The firm failed to establish and follow procedures for preventing microbial contamination, adequately monitor environmental conditions, and ensure proper in-process specifications. Additional issues included inadequate cleaning validation, equipment design, quality control unit procedures, employee training, and batch record documentation.