fda_483 · inspection_citation · high
NerPharMa S.r.l. -- FDA 483: 1 observation (2025-06-27)
- Event date
- 2025-06-27 00:00:00Z
- Observed
- 2026-07-12 22:32:05Z
- Source ID
- 3004762406-2025-06-27-189639
- Payload hash
- 8572b3e44269e75a7fa64bfe…
Summary
Observation 1: Procedures designed to prevent microbiological contamination of diug products pmpo1ting to be sterile did not include adequate validation of the aseptic and sterilization process. Speci...
Entities
Informational only. Not legal, financial, or medical advice.