FDA 483 - NerPharMa S.r.l. - June 19, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 665c1740-e571-418a-a5d0-7f768a20b6ee