Overview
- 8 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2013-12-16.
At a glance
Inspections
8
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Dec 2013 – 16 Dec 2013 | Medical Devices & Rad Health | Clean | |
| 11 Mar 2013 – 14 Mar 2013 | Medical Devices & Rad Health | Clean | |
| 16 Jun 2011 | Not recorded | Clean | |
| 18 Nov 2008 | Not recorded | 483 | View 483 → |
| 9 Jan 2008 | Not recorded | Clean | |
| 15 Jun 2004 | Not recorded | Clean | |
| 13 May 2002 | Not recorded | Clean | |
| 21 Dec 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Nov 2008
21 CFR 820.30(f)
Design verification procedures
Cited by Catherine M Beer, Michael G Sinkevich
Investigators
FDA investigators tied to this site in the record.
Catherine M Beer3 insp.
Michael G Sinkevich3 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Covidien's 1 Form 483
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