Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-07-10.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Jul 2024 – 10 Jul 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 Mar 2015 – 12 Mar 2015 | Medical Devices & Rad Health | Clean | |
| 17 Sep 2012 | Not recorded | Clean | |
| 8 Sep 2010 | Not recorded | 483 | View 483 → |
| 6 Mar 2008 | Not recorded | Clean | |
| 13 Apr 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Jul 2024
21 CFR 820.250(b)
Sampling methods - Lack of or inadequate procedures
Cited by Stephen R Souza
10 Jul 2024
21 CFR 820.250(b)
Sampling methods - Lack of or inadequate procedures
Cited by Stephen R Souza
10 Jul 2024
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Stephen R Souza
10 Jul 2024
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Stephen R Souza
Investigators
FDA investigators tied to this site in the record.
Lori J Silverstein2 insp.
Stephen R Souza1 insp.
Sharon I Gundersen1 insp.
Christine M Parmentier1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Ameritek USA, 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