Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-11-09.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Nov 2023 – 9 Nov 2023 | Medical Devices & Rad Health | Clean | |
| 28 Feb 2020 – 4 Mar 2020 | Medical Devices & Rad Health | Clean | |
| 3 Apr 2017 – 7 Apr 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 22 Mar 2011 | Not recorded | Clean | |
| 2 May 2008 | Not recorded | 483 | On file |
| 28 Aug 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
7 Apr 2017
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Bonnie E Conley
Investigators
FDA investigators tied to this site in the record.
Jamie P Webb1 insp.
Adaliz Santaliz-Cruz1 insp.
Laiza V Garcia1 insp.
Nikki S Bryant1 insp.
Joseph J Stanek1 insp.
Bonnie E Conley1 insp.
Cheryl G Scott1 insp.
Travis E Chapman1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Southeastern Technology Inc. dba Autocam Medical'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