Overview
- 9 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-29.
At a glance
Inspections
9
Form 483s
4
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Aug 2025 – 29 Aug 2025 | Biologics | Clean | |
| 30 May 2018 – 8 Jun 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 May 2014 – 13 Jun 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 25 Sep 2013 – 29 Oct 2013 | Biologics | Clean | |
| 12 Apr 2012 | Not recorded | Clean | |
| 7 Oct 2011 | Not recorded | 483 | On file |
| 27 Jul 2010 | Not recorded | 483 | View 483 → |
| 4 Mar 2003 | Not recorded | Clean | |
| 18 Feb 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Jun 2018
21 CFR 820.50(a)
Evaluation of suppliers, contractors, etc., requirements
Cited by Elizabeth B Griffin
8 Jun 2018
21 CFR 820.50(a)
Evaluation of suppliers, contractors, etc., requirements
Cited by Elizabeth B Griffin
8 Jun 2018
21 CFR 820.50(a)
Evaluation of suppliers, contractors, etc., requirements
Cited by Elizabeth B Griffin
8 Jun 2018
21 CFR 820.50(a)
Evaluation of suppliers, contractors, etc., requirements
Cited by Elizabeth B Griffin
Investigators
FDA investigators tied to this site in the record.
Elizabeth B Griffin2 insp.
David E Lowe1 insp.
Jacqueline M Diaz Albert1 insp.
Sandra P White1 insp.
Qiao Y Bobo1 insp.
Gang Wang1 insp.
Abby E Pelletier1 insp.
Allison A Rodriguez1 insp.
Maura Rooney1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 806.10(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Organogenesis, Inc.'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