Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2014-11-03.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Nov 2014 | Medical Devices & Rad Health | Clean | |
| 14 Mar 2013 – 19 Mar 2013 | Medical Devices & Rad Health | WL | On file |
| 13 Nov 2012 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Nov 2012
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Hala L Selby, Lauren E Skokan
13 Nov 2012
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Hala L Selby, Lauren E Skokan
13 Nov 2012
21 CFR 211.84(d)(1)
Identity Testing of Each Component
Cited by Hala L Selby, Lauren E Skokan
Investigators
FDA investigators tied to this site in the record.
Janet B Abt1 insp.
Jeffrey R Wooley1 insp.
Saijal Naik1 insp.
Hala L Selby1 insp.
Lauren E Skokan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.150 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(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 211.84(d)(1) | 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 American Aesthetics Medical Supply, 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