Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-04-27.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 26 Apr 2017 – 27 Apr 2017 | Foods & Cosmetics | Clean | |
| 1 Jun 2011 | Not recorded | Clean | |
| 22 Mar 2011 | Not recorded | 483 | On file |
| 12 Feb 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Feb 2010
21 CFR 211.22(a)
Lack of quality control unit
Cited by Elizabeth L Edwards, Tamara M Kays, Benjamin D Motsinger
12 Feb 2010
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Elizabeth L Edwards, Tamara M Kays, Benjamin D Motsinger
12 Feb 2010
21 CFR 211.52
Washing and toilet facilities are deficient
Cited by Elizabeth L Edwards, Tamara M Kays, Benjamin D Motsinger
12 Feb 2010
21 CFR 211.56(c)
Written procedures lacking for use of pesticides etc.
Cited by Elizabeth L Edwards, Tamara M Kays, Benjamin D Motsinger
12 Feb 2010
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Elizabeth L Edwards, Tamara M Kays, Benjamin D Motsinger
Investigators
FDA investigators tied to this site in the record.
Tamara M Kays3 insp.
Luckner Jean-Marie1 insp.
Talmane J Fisher1 insp.
Elizabeth L Edwards1 insp.
Benjamin D Motsinger1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.105(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.137(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.150(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | 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 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.52 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(c) | 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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Cosmed Labs Inc's 2 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