Overview
- 11 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-12-08.
At a glance
Inspections
11
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Nov 2023 – 8 Dec 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 25 Oct 2021 – 28 Oct 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Mar 2020 – 11 Mar 2020 | Medical Devices & Rad Health | Clean | |
| 23 Jan 2017 – 27 Jan 2017 | Medical Devices & Rad Health | Clean | |
| 21 Jul 2015 – 24 Jul 2015 | Medical Devices & Rad Health | Clean | |
| 24 Jun 2013 – 28 Jun 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 21 Oct 2009 | Not recorded | 483 | View 483 → |
| 1 Feb 2008 | Not recorded | Clean | |
| 28 Jan 2008 | Not recorded | Clean | |
| 11 Oct 2006 | Not recorded | Clean | |
| 1 Feb 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Dec 2023
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by James R Montero, Jacey Roy
8 Dec 2023
21 CFR 820.80(a)
Lack of or inadequate procedures - Acceptance activities
Cited by James R Montero, Jacey Roy
Investigators
FDA investigators tied to this site in the record.
Iris C Macinnes3 insp.
James R Montero1 insp.
Jacey Roy1 insp.
Daniel J Lahar1 insp.
William H Shackelford1 insp.
CntrctMntr YoungJD1 insp.
Lorie S Hannappel1 insp.
Charles D Brown1 insp.
Robert T Lorenz1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 806.10(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Encore Medical, LP's 4 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