Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-20.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Aug 2025 – 20 Aug 2025 | Human Drugs | Clean | |
| 16 Apr 2019 – 18 Apr 2019 | Human Drugs | 483 | View 483 → |
| 10 Apr 2017 – 11 Apr 2017 | Human Drugs | 483 | View 483 → |
| 11 Feb 2016 | Medical Devices & Rad Health | Clean | |
| 21 Mar 2012 | Not recorded | 483 | View 483 → |
| 6 May 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Apr 2017
21 CFR 211.100(a)
Changes to Procedures Not Reviewed, Approved
Cited by Daveta L Bailey, Lillie D Witcher
Investigators
FDA investigators tied to this site in the record.
Stephon D Tillis1 insp.
Gideon N Esuzor1 insp.
Daveta L Bailey1 insp.
Lillie D Witcher1 insp.
Perry H Gambrell1 insp.
Viviana Matta1 insp.
Jawaid Hamid1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.150(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.180(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.115(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.134(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.204 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Acme United Corporation's 4 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