Overview
- 5 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-12-06.
At a glance
Inspections
5
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Nov 2022 – 6 Dec 2022 | Human Drugs | 483 | On file |
| 8 Apr 2019 – 11 Apr 2019 | Medical Devices & Rad Health | 483 | On file |
| 28 Oct 2015 – 24 Nov 2015 | Human Drugs | 483 | On file |
| 1 Nov 2012 | Not recorded | 483 | On file |
| 5 Nov 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Dec 2022
21 CFR 211.22(a)
Authority lacking to review records, investigate errors
Cited by Kayla V Sprague
11 Apr 2019
21 CFR 820.25(b)
Training records
Cited by Stanley B Eugene
11 Apr 2019
21 CFR 820.25(b)
Training records
Cited by Stanley B Eugene
Investigators
FDA investigators tied to this site in the record.
Kayla V Sprague1 insp.
Stanley B Eugene1 insp.
Michael H Tollon1 insp.
Nicole E Knowlton1 insp.
Mizanne E Lewis1 insp.
Leo J Lagrotte1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.72(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.101(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(d) | 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 Dermazone LLC'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