Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2023-02-22.
At a glance
Inspections
5
Form 483s
1
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Feb 2023 – 22 Feb 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 12 Aug 2014 – 13 Aug 2014 | Medical Devices & Rad Health | Clean | |
| 26 Jun 2012 | Not recorded | Clean | |
| 16 Apr 2009 | Not recorded | Clean | |
| 4 Apr 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Feb 2023
21 CFR 820.75(b)(2)
Documentation of validated process performance
Cited by Stephen C Smith
Investigators
FDA investigators tied to this site in the record.
Stephen C Smith2 insp.
Laurie B Frazier2 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.86 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind AADCO Medical Inc.'s 1 Form 483
Source PDFs 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