Overview
- 11 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-10-30.
At a glance
Inspections
11
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Oct 2024 – 30 Oct 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 30 Oct 2023 – 8 Nov 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 Apr 2022 – 20 May 2022 | Medical Devices & Rad Health | 483 | On file |
| 27 Jun 2016 – 28 Jun 2016 | Medical Devices & Rad Health | Clean | |
| 25 Jun 2015 – 6 Jul 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 30 Aug 2013 – 10 Sep 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 Apr 2013 – 5 Apr 2013 | Medical Devices & Rad Health | Clean | |
| 11 Jul 2012 | Not recorded | Clean | |
| 1 Feb 2010 | Not recorded | Clean | |
| 19 Nov 2001 | Not recorded | Clean | |
| 13 Jun 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Oct 2024
21 CFR 803.50(a)(1)
Report of Death or Serious Injury
Cited by Edward E Lockwood, Clifford F Long
30 Oct 2024
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Edward E Lockwood, Clifford F Long
30 Oct 2024
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Edward E Lockwood, Clifford F Long
30 Oct 2024
21 CFR 820.70(e)
Contamination control, Lack of or inadequate procedures
Cited by Edward E Lockwood, Clifford F Long
30 Oct 2024
21 CFR 820.75(a)
Lack of or inadequate process validation
Cited by Edward E Lockwood, Clifford F Long
Investigators
FDA investigators tied to this site in the record.
Edward E Lockwood3 insp.
Clifford F Long2 insp.
Steven D Kehoe2 insp.
Eric M Padgett2 insp.
Mary L Schuckmann1 insp.
Dustin K Hampton1 insp.
Karen M Montgomery1 insp.
Dawn C Olenjack1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 806.10(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.200(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | 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 Allied Medical LLC'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