Overview
- 8 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-10-20.
At a glance
Inspections
8
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Oct 2023 – 20 Oct 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 Jul 2021 – 27 Jul 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 2 Jul 2018 – 6 Jul 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 15 Apr 2015 – 16 Apr 2015 | Medical Devices & Rad Health | Clean | |
| 11 Dec 2012 | Not recorded | Clean | |
| 15 Oct 2010 | Not recorded | 483 | View 483 → |
| 22 Oct 2008 | Not recorded | 483 | View 483 → |
| 21 Aug 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Jul 2021
21 CFR 820.250(a)
Statistical techniques - Lack of or inadequate procedures
Cited by Jacqueline S Warner
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.186 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.120(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind A.M. Surgical, Inc.'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