Overview
- 17 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-09-29.
At a glance
Inspections
17
Form 483s
4
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Sep 2021 – 29 Sep 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Nov 2017 – 30 Nov 2017 | Medical Devices & Rad Health | 483 | On file |
| 30 Nov 2016 – 2 Dec 2016 | Medical Devices & Rad Health | Clean | |
| 6 Jun 2016 | Biologics | Clean | |
| 28 Jan 2016 – 29 Jan 2016 | Medical Devices & Rad Health | 483 | On file |
| 22 May 2014 | Medical Devices & Rad Health | Clean | |
| 18 Mar 2013 – 21 Mar 2013 | Biologics | 483 | View 483 → |
| 20 Aug 2010 | Not recorded | Clean | |
| 15 Apr 2010 | Not recorded | Clean | |
| 17 Sep 2009 | Not recorded | Clean | |
| 11 Jan 2008 | Not recorded | Clean | |
| 15 Sep 2006 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Sep 2021
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Mary A Millner, Javelle P Spann
29 Sep 2021
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Mary A Millner, Javelle P Spann
29 Sep 2021
21 CFR 820.75(b)
Lack/Inad procedure-Monitoring/Control of Validated Proces
Cited by Mary A Millner, Javelle P Spann
29 Sep 2021
21 CFR 820.75(b)
Lack/Inad procedure-Monitoring/Control of Validated Proces
Cited by Mary A Millner, Javelle P Spann
Investigators
FDA investigators tied to this site in the record.
MDSAP harperd2 insp.
Mary A Millner1 insp.
Javelle P Spann1 insp.
Cody D Rickman1 insp.
MDSAP WilliamsA1 insp.
Bonnie E Conley1 insp.
Bonnie E Pierson1 insp.
Danielle M Maddox1 insp.
Samantha J Bradley1 insp.
Dana M Klimavicz1 insp.
Barbara D Wright1 insp.
Erica M Katherine1 insp.
Marcus L Head1 insp.
Stephanie A Cochran1 insp.
Karen R Smallwood1 insp.
Travis E Chapman1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.180(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.230(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.260(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.260(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Wright Medical Technology, Inc.'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