NerPharMa S.r.l.
Form 483 issued February 20, 2023 · Nerviano, Italy
- Investigator
- Ei Orig Lf
- Observations
- 9
- Pages
- 6
- FEI number
- 3004762406
In short: On February 20, 2023, FDA issued a Form 483 with 9 observations to NerPharMa S.r.l. in Nerviano, Milano (FEI 3004762406). The investigator was Ei Orig Lf. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Laboratory controls and quality system account for 6 of 9 observations.
Most cited: 21 CFR 211.192 (2×) · 211.160 (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 aia to be…
- 02
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 03
Electronic records are used, but they do not meet retention, system access limitation, audit trail, employee…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Ei Orig Lf
1 document · 2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Italy.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at NerPharMa S.r.l.?
FDA listed 9 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected NerPharMa S.r.l.?
Ei Orig Lf is named on this Form 483. Each investigator has a profile showing what they cite most.
When was NerPharMa S.r.l. inspected by FDA?
This Form 483 is dated February 20, 2023.
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.