NerPharMa S.r.l.
Form 483 issued June 19, 2024 · Nerviano, Italy
- Inspection
- Jun 10 – Jun 19, 2024
- Investigator
- Ruo H. Xu
- Observations
- 8
- Pages
- 6
- FEI number
- 3004762406
In short: On June 19, 2024, FDA issued a Form 483 with 8 observations to NerPharMa S.r.l. in Nerviano, Milano (FEI 3004762406) after an inspection that ran Jun 10 – Jun 19, 2024. The investigator was Ruo H. Xu. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and facilities & equipment account for 6 of 8 observations.
Most cited: 21 CFR 211.110 (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 are not…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
In-process specifications are not derived from previous acceptable process average and process variability estimates where possible…
- 04
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
This inspection in context
Ruo H. Xu
4 documents · 2017–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.
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 211.110
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 production, facilities & equipment 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.?
Ruo H. Xu is named on this Form 483, for the inspection of Jun 10 – Jun 19, 2024. Each investigator has a profile showing what they cite most.
When was NerPharMa S.r.l. inspected by FDA?
The inspection ran Jun 10 – Jun 19, 2024, and the Form 483 is dated June 19, 2024.
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.