Overview
- 9 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2014-04-23.
At a glance
Inspections
9
Form 483s
3
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Apr 2014 – 23 Apr 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 22 Apr 2013 – 2 May 2013 | Medical Devices & Rad Health | Clean | |
| 19 Jan 2012 | Not recorded | 483 | View 483 → |
| 31 May 2011 | Not recorded | 483 | On file |
| 7 Oct 2010 | Not recorded | Clean | |
| 28 Aug 2009 | Not recorded | Clean | |
| 18 Jun 2009 | Not recorded | Clean | |
| 13 Jun 2003 | Not recorded | Clean | |
| 30 Nov 1999 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Jessica L Johnson3 insp.
James A Beaulieu3 insp.
Aaron L Dunbar2 insp.
Susan M Matthias1 insp.
Marissa S Henning1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 806.10(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Smiths Medical ASD, 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