Overview
- 11 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-13.
At a glance
Inspections
11
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Nov 2024 – 13 Jan 2025 | Foods & Cosmetics | WL | View 483 → |
| 15 Aug 2022 – 31 Aug 2022 | Foods & Cosmetics | 483 | View 483 → |
| 3 Aug 2018 – 6 Aug 2018 | Foods & Cosmetics | Clean | |
| 9 Aug 2017 – 18 Aug 2017 | Foods & Cosmetics | 483 | View 483 → |
| 17 Jun 2015 – 16 Jul 2015 | Foods & Cosmetics | 483 | On file |
| 2 Oct 2012 | Not recorded | Clean | |
| 3 Feb 2011 | Not recorded | Clean | |
| 11 Sep 2009 | Not recorded | Clean | |
| 25 Oct 2001 | Not recorded | Clean | |
| 23 Jul 2001 | Not recorded | Clean | |
| 17 Nov 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Jan 2025
21 CFR 111.113(a)(1)
Quality control production, process control; material review, disposition
Cited by Courtney R Ingalsbe, Rebecca L Keller
13 Jan 2025
21 CFR 111.255(c)
Batch record - follow master
Cited by Courtney R Ingalsbe, Rebecca L Keller
13 Jan 2025
21 CFR 111.260
Batch record - required information
Cited by Courtney R Ingalsbe, Rebecca L Keller
13 Jan 2025
21 CFR 111.320(a)
Examination, testing; appropriate
Cited by Courtney R Ingalsbe, Rebecca L Keller
Investigators
FDA investigators tied to this site in the record.
Courtney R Ingalsbe2 insp.
Douglas J Snyder2 insp.
Kibily D Dembele2 insp.
Marie A Fadden2 insp.
Rebecca L Keller1 insp.
Krista K Petersen1 insp.
Mada A Tautges1 insp.
Ivan E Reyes1 insp.
David B Wieneke1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.113(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.10(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.10(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.113(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.15(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(l)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(d)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.320(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.320(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.365(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.560(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(D) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.83 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Eniva USA, Inc.'s 4 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