Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-12-14.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Dec 2018 – 14 Dec 2018 | Medical Devices & Rad Health | 483 | On file |
| 23 Apr 2018 – 26 Apr 2018 | Medical Devices & Rad Health | Clean | |
| 2 Mar 2015 – 5 Mar 2015 | Medical Devices & Rad Health | Clean | |
| 23 Aug 2012 | Not recorded | 483 | View 483 → |
| 30 Sep 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Aug 2012
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Thai T Duong
30 Sep 2010
21 CFR 820.20(c)
Management review - Lack of or inadequate procedures
Cited by Stephen D Eich
Investigators
FDA investigators tied to this site in the record.
MDSAP harperd1 insp.
Natasha N Mccants1 insp.
Meredith L Sheridan1 insp.
Thai T Duong1 insp.
Stephen D Eich1 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 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Integra Lifesciences (Ireland) Limited's 3 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