Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2016-09-20.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Sep 2016 – 20 Sep 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 May 2013 – 16 May 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 17 May 2012 | Not recorded | 483 | View 483 → |
| 15 Jun 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Sep 2016
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Mary R Hole
20 Sep 2016
21 CFR 820.70(g)
Equipment Installation, Placement, Specified Requirements
Cited by Mary R Hole
20 Sep 2016
21 CFR 820.70(g)
Equipment Installation, Placement, Specified Requirements
Cited by Mary R Hole
Investigators
FDA investigators tied to this site in the record.
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 820.70(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.70(g) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.50(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Covidien, LLC's 4 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