NerPharMa S.r.l.
Form 483 issued June 27, 2025 · Nerviano, Milan, Italy
- Inspection
- Jun 16 – Jun 27, 2025
- Investigators
- Eileen A. Liu· Jeffrey P. Raimondi
- Observations
- 8
- Pages
- 13
- FEI number
- 3004762406
In short: On June 27, 2025, FDA issued a Form 483 with 8 observations to NerPharMa S.r.l. in Nerviano, Milan, Milan (FEI 3004762406) after an inspection that ran Jun 16 – Jun 27, 2025. The investigators were Eileen A. Liu and Jeffrey P. Raimondi. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 5 of 8 observations.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
Written records are not always made of investigations into unexplained discrepancies and the failure of a…
This inspection in context
Eileen A. Liu
41 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmNerPharMa S.r.l. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at NerPharMa S.r.l.?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected NerPharMa S.r.l.?
Eileen A. Liu and Jeffrey P. Raimondi are named on this Form 483, for the inspection of Jun 16 – Jun 27, 2025. Each investigator has a profile showing what they cite most.
When was NerPharMa S.r.l. inspected by FDA?
The inspection ran Jun 16 – Jun 27, 2025, and the Form 483 is dated June 27, 2025.
How do I get the full Form 483 for NerPharMa S.r.l.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.