Overview
- 5 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-14.
At a glance
Inspections
5
Form 483s
5
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Nov 2025 – 14 Nov 2025 | Human Drugs | 483 | On file |
| 3 Jun 2019 – 11 Jun 2019 | Human Drugs | 483 | On file |
| 23 Jan 2017 – 31 Jan 2017 | Human Drugs | 483 | On file |
| 14 Dec 2015 – 17 Dec 2015 | Human Drugs | WL | View 483 → |
| 24 Jun 2010 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Dec 2015
21 CFR 211.101(b)(4)
Subdivided component/container/finished drug
Cited by Roger F Zabinski
17 Dec 2015
21 CFR 211.94(c)
Containers & Closures Clean, Sterilized, Pyrogen-free
Cited by Roger F Zabinski
Investigators
FDA investigators tied to this site in the record.
Gavin T Cua1 insp.
Tonia F Bernard1 insp.
Saleem A Akhtar1 insp.
Samantha J Bradley1 insp.
Roger F Zabinski1 insp.
Ginger M Sykes1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.101(b)(4) | 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 |
| 21 CFR 211.94(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Nippon Fine Chemical Co., Ltd.'s 5 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