FDA 483 - NerPharMa S.r.l.

An FDA inspection of NerPharMa S.r.l. in Nerviano, Milan, Italy, revealed significant deficiencies in their manufacturing and laboratory operations. Key issues include inadequate procedures for preventing microbiological contamination of sterile drug products, incomplete and unreliable electronic laboratory records, and a failure to thoroughly investigate unexplained discrepancies and batch rejections. The firm also demonstrated shortcomings in personnel training, environmental monitoring, and instrument calibration procedures.