Overview
- 10 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-11-27.
At a glance
Inspections
10
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Nov 2024 – 27 Nov 2024 | Foods & Cosmetics | 483 | View 483 → |
| 29 Jul 2019 – 7 Aug 2019 | Foods & Cosmetics | 483 | View 483 → |
| 19 May 2016 | Foods & Cosmetics | Clean | |
| 15 Oct 2014 – 30 Oct 2014 | Foods & Cosmetics | 483 | View 483 → |
| 7 Oct 2010 | Not recorded | 483 | View 483 → |
| 7 Jan 2009 | Not recorded | 483 | View 483 → |
| 26 Feb 2008 | Not recorded | 483 | On file |
| 23 Aug 2005 | Not recorded | Clean | |
| 24 May 2004 | Not recorded | Clean | |
| 14 Feb 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Kevin T Gerrity2 insp.
James A Barreto1 insp.
Kimberly M Lichter1 insp.
Joseph C Francisco1 insp.
Eileen T Dupont1 insp.
Natalie J Ayoub1 insp.
Troy D Mansell1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 108.25(c)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 108.25(c)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.10(b)(5) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.80(b)(5) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 114.80(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.35(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 123.12(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.10(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.93 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.11(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Niitakaya USA Inc's 6 Form 483s
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