Overview
- 8 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-06-27.
At a glance
Inspections
8
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Jun 2022 – 27 Jun 2022 | Human Drugs | 483 | View 483 → |
| 3 Apr 2019 – 10 Apr 2019 | Human Drugs | 483 | View 483 → |
| 25 Nov 2013 – 4 Dec 2013 | Human Drugs | 483 | View 483 → |
| 19 Apr 2011 | Not recorded | Clean | |
| 2 Jul 2009 | Not recorded | 483 | View 483 → |
| 12 Aug 2005 | Not recorded | Clean | |
| 29 Sep 2004 | Not recorded | Clean | |
| 10 Sep 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Jun 2022
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Jacob G Lutz, Brent M Dehaan
27 Jun 2022
21 CFR 211.166(a)(4)
Testing in same container - closure system
Cited by Jacob G Lutz, Brent M Dehaan
Investigators
FDA investigators tied to this site in the record.
Andrew J Lang2 insp.
Jacob G Lutz1 insp.
Brent M Dehaan1 insp.
Jazmine N Still1 insp.
Janet L Bowen1 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 | 3x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.130(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Akron Coating & Adhesives' 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