Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-01-12.
At a glance
Inspections
7
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Jan 2023 – 12 Jan 2023 | Medical Devices & Rad Health | 483 | On file |
| 5 Feb 2018 – 8 Feb 2018 | Medical Devices & Rad Health | Clean | |
| 3 Apr 2017 – 6 Apr 2017 | Medical Devices & Rad Health | Clean | |
| 4 May 2015 – 7 May 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Feb 2013 – 22 Feb 2013 | Medical Devices & Rad Health | Clean | |
| 22 Jul 2010 | Not recorded | WL | On file |
| 13 Nov 2008 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
7 May 2015
21 CFR 820.75(b)
Lack/Inad procedure-Monitoring/Control of Validated Proces
Cited by Thomas A Peter
7 May 2015
21 CFR 820.75(b)
Lack/Inad procedure-Monitoring/Control of Validated Proces
Cited by Thomas A Peter
Investigators
FDA investigators tied to this site in the record.
Felix J Marrero1 insp.
Lauren E Priest1 insp.
Iris C Macinnes1 insp.
Thomas A Peter1 insp.
Yvette M Lacour-Davis1 insp.
Paul W Moy1 insp.
Elizabeth B Griffin1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Smith & Nephew Orthopaedics GmbH's 4 Form 483s
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