Overview
- 12 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-12-09.
At a glance
Inspections
12
Form 483s
3
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Dec 2021 – 9 Dec 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 31 Jan 2018 – 2 Feb 2018 | Medical Devices & Rad Health | Clean | |
| 24 Jul 2017 – 2 Aug 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 15 Aug 2016 – 17 Aug 2016 | Medical Devices & Rad Health | Clean | |
| 25 Jun 2014 – 27 Jun 2014 | Medical Devices & Rad Health | Clean | |
| 23 Apr 2009 | Not recorded | 483 | View 483 → |
| 22 Aug 2008 | Not recorded | Clean | |
| 18 Jan 2007 | Not recorded | Clean | |
| 11 Nov 2005 | Not recorded | Clean | |
| 15 Jan 2003 | Not recorded | Clean | |
| 20 Nov 2001 | Not recorded | Clean | |
| 12 Apr 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Aug 2017
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Bonnie E Conley, Mary A Millner
2 Aug 2017
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Bonnie E Conley, Mary A Millner
Investigators
FDA investigators tied to this site in the record.
Mary A Millner2 insp.
Bonnie E Conley2 insp.
Wendy R Blame2 insp.
Shafiq Ahadi1 insp.
Bonnie E Pierson1 insp.
Thomas O Morgan1 insp.
Travis E Chapman1 insp.
Natasha N Mccants1 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 | 3x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Smith & Nephew, Inc.'s 3 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