Overview
- 12 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-11-21.
At a glance
Inspections
12
Form 483s
5
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Nov 2024 – 21 Nov 2024 | Medical Devices & Rad Health | Clean | |
| 11 Feb 2020 – 28 Feb 2020 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 Feb 2020 – 14 Feb 2020 | Medical Devices & Rad Health | 483 | View 483 → |
| 29 Aug 2017 – 1 Sep 2017 | Medical Devices & Rad Health | Clean | |
| 11 Aug 2014 – 14 Aug 2014 | Medical Devices & Rad Health | Clean | |
| 6 Dec 2012 | Not recorded | 483 | On file |
| 9 Feb 2012 | Not recorded | 483 | View 483 → |
| 16 Jun 2011 | Not recorded | 483 | On file |
| 8 Nov 2010 | Not recorded | Clean | |
| 1 Sep 2009 | Not recorded | Clean | |
| 29 Oct 2004 | Not recorded | Clean | |
| 18 Nov 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Feb 2012
21 CFR 806.10(a)(2)
Report of violation of the Act (see 803.52(e)(9))
Cited by Jeffrey J Thibodeau, Edward J Janik
Investigators
FDA investigators tied to this site in the record.
Michael G Mayfield3 insp.
Jeffrey J Thibodeau2 insp.
Edward J Janik2 insp.
Katarzyna Plona1 insp.
MDSAP harperd1 insp.
James W Whitney1 insp.
Darin S Wiegers1 insp.
Amy M Cramer1 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 | 4x |
| 21 CFR 806.10(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 806.30 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.120 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Covidien, LP's 5 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