NerPharMa S.r.l.
FDA inspection history across 2 sites, 2023 to 2025
- 3
- Form 483s
Every document, by year
- Form 483
2023: one Form 483; 2024: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023–25Three Form 483s, at Nerviano, Italy and Nerviano, Milan, Italy.
- 2025The longest 483 on file: 8 observations over 13 pages at Nerviano, Milan, Italy.
Cited most
Across all NerPharMa S.r.l. observations on file
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.160General requirements3
- 21 CFR 211.192Production record review3
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
The complete NerPharMa S.r.l. file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Nerviano, Italy
Two Form 483s · 2023 to 2024 · 8 observations
Latest: Form 483, Jun 19, 2024 →Nerviano, Milan, Italy
One Form 483 · 2025 · 8 observations
Latest: Form 483, Jun 27, 2025 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-06-27 | 483 Form 483 | Nerviano, Milan, Italy | 8 | $99 |
| 2024-06-19 | 483 Form 483 | Nerviano, Italy | 8 | $99 |
| 2023-02-20 | 483 Form 483 | Nerviano, Italy | — | $99 |
Investigators on these documents
Ei Orig Lf (1)Eileen A. Liu (1)Jeffrey P. Raimondi (1)Ruo H. Xu (1)
FEI number 3004762406 · most recent document Jun 27, 2025
About NerPharMa S.r.l.
How many FDA Form 483s has NerPharMa S.r.l. received?
FDA Intel has 3 Form 483s on file for NerPharMa S.r.l.; the most recent is dated Jun 27, 2025.
When was NerPharMa S.r.l. last inspected by FDA?
The most recent FDA inspection document on file for NerPharMa S.r.l. is a Form 483 dated Jun 27, 2025, for the site in Nerviano, Milan, Italy.
What did FDA cite at NerPharMa S.r.l.?
The regulations cited most in the observations on file for NerPharMa S.r.l. are 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.160 (General requirements), 3 times; 21 CFR 211.192 (Production record review), 3 times.