Overview
- 11 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-06-27.
At a glance
Inspections
11
Form 483s
7
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Jun 2025 – 27 Jun 2025 | Human Drugs | 483 | View 483 → |
| 9 Sep 2024 – 13 Sep 2024 | Human Drugs | Clean | |
| 10 Jun 2024 – 19 Jun 2024 | Human Drugs | 483 | On file |
| 6 Feb 2023 – 20 Feb 2023 | Human Drugs | 483 | On file |
| 22 Oct 2018 – 26 Oct 2018 | Human Drugs | Clean | |
| 25 May 2017 – 1 Jun 2017 | Human Drugs | 483 | On file |
| 23 Feb 2015 – 5 Mar 2015 | Human Drugs | 483 | View 483 → |
| 12 Dec 2012 | Not recorded | Clean | |
| 19 Jul 2010 | Not recorded | Clean | |
| 30 Oct 2009 | Not recorded | 483 | On file |
| 26 Sep 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Jun 2025
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Jeffrey P Raimondi, Eileen A Liu
27 Jun 2025
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Jeffrey P Raimondi, Eileen A Liu
27 Jun 2025
21 CFR 211.192
No written record of investigation
Cited by Jeffrey P Raimondi, Eileen A Liu
27 Jun 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jeffrey P Raimondi, Eileen A Liu
Investigators
FDA investigators tied to this site in the record.
Jeffrey P Raimondi2 insp.
Eileen A Liu1 insp.
MRA MunizN1 insp.
Ruo H Xu1 insp.
Daniel L Obrzut1 insp.
Susan T Hadman1 insp.
Cynthia Jim1 insp.
Kham Phommachanh1 insp.
Kejun Cheng1 insp.
Lucas B Leake1 insp.
Patric C Klotzbuecher1 insp.
Junho Pak1 insp.
Brittany D Terhar1 insp.
Deborah A Greco1 insp.
Carla A Norris1 insp.
Simone E Pitts1 insp.
Susan M Jackson1 insp.
Barbara D Paul1 insp.
Kristy A Zielny1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind NerPharMa S.r.l.'s 7 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat