Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2025-09-17.
At a glance
Inspections
5
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Sep 2025 – 17 Sep 2025 | Medical Devices & Rad Health | Clean | |
| 20 Oct 2016 – 21 Oct 2016 | Medical Devices & Rad Health | Clean | |
| 29 Apr 2013 – 1 May 2013 | Medical Devices & Rad Health | Clean | |
| 20 Jan 2010 | Not recorded | 483 | View 483 → |
| 17 Mar 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Jan 2010
21 CFR 820.80(a)
Lack of or inadequate procedures - Acceptance activities
Cited by James R Montero, Ginger M Sykes
20 Jan 2010
21 CFR 820.80(d)(2)
Review of data and documentation
Cited by James R Montero, Ginger M Sykes
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 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Integra LifeSciences Corporation's 1 Form 483
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