Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-02-15.
At a glance
Inspections
6
Form 483s
2
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Feb 2018 – 15 Feb 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 Sep 2016 – 22 Sep 2016 | Medical Devices & Rad Health | Clean | |
| 12 May 2014 – 15 May 2014 | Medical Devices & Rad Health | Clean | |
| 21 Jun 2012 | Not recorded | Clean | |
| 21 Jan 2010 | Not recorded | 483 | View 483 → |
| 27 Mar 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Feb 2018
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Lauren E Priest
21 Jan 2010
21 CFR 820.80(b)
Lack of or inadequate receiving acceptance procedures
Cited by Stephen D Eich
Investigators
FDA investigators tied to this site in the record.
Lauren E Priest1 insp.
David H Smith1 insp.
Yehualashe A Gessesse1 insp.
Patrick B Cummings1 insp.
Stephen D Eich1 insp.
David P Vanhouten1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Smith & Nephew Orthopaedics Ltd. (Aurora)'s 2 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