Overview
- 9 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-17.
At a glance
Inspections
9
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Apr 2026 – 17 Apr 2026 | Biologics | Clean | |
| 5 Jun 2023 – 8 Jun 2023 | Biologics | Clean | |
| 12 Jun 2017 – 16 Jun 2017 | Biologics | 483 | View 483 → |
| 20 Aug 2015 – 26 Aug 2015 | Biologics | 483 | View 483 → |
| 5 Jun 2013 – 11 Jun 2013 | Biologics | Clean | |
| 12 May 2011 | Not recorded | 483 | View 483 → |
| 11 Sep 2009 | Not recorded | 483 | View 483 → |
| 18 Jan 2007 | Not recorded | Clean | |
| 10 May 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Jun 2017
21 CFR 1271.160(a)
All core requirements covered in program
Cited by Travis R Hunt, Amanda B Athey
16 Jun 2017
21 CFR 1271.160(a)
All core requirements covered in program
Cited by Travis R Hunt, Amanda B Athey
Investigators
FDA investigators tied to this site in the record.
Travis R Hunt4 insp.
Carl E Lovrich2 insp.
Michele Gottshall1 insp.
Nisha C Patel1 insp.
Amanda B Athey1 insp.
Brandon M Kurjanowicz1 insp.
Erica L Nicoll1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.160(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.200(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.290(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.160(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.160(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.180(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.230(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.250(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.265(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.270(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.290(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.320(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Center For Organ Recovery & Education'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