Overview
- 14 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-12.
At a glance
Inspections
14
Form 483s
9
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 1 Jun 2026 – 12 Jun 2026 | Biologics | 483 | View 483 → |
| 18 Sep 2024 – 25 Sep 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 13 Jul 2023 – 21 Jul 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 May 2016 – 27 May 2016 | Biologics | 483 | On file |
| 9 May 2016 – 13 May 2016 | Biologics | 483 | On file |
| 11 Mar 2014 – 19 Mar 2014 | Biologics | 483 | On file |
| 27 Sep 2011 | Not recorded | 483 | On file |
| 21 Aug 2009 | Not recorded | 483 | View 483 → |
| 19 Sep 2008 | Not recorded | 483 | On file |
| 22 Aug 2007 | Not recorded | Clean | |
| 29 Mar 2005 | Not recorded | Clean | |
| 14 Jan 2003 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Jun 2026
21 CFR 211.105(b)
Distinctive ID or code not recorded in batch record
Cited by Richard L Bartlett
Investigators
FDA investigators tied to this site in the record.
Richard L Bartlett1 insp.
James P Finn1 insp.
Gene D Arcy1 insp.
Nancy L Neiger1 insp.
Laurel A Beer1 insp.
Simone E Pitts1 insp.
Pankaj H Amin1 insp.
Jacqueline M Diaz Albert1 insp.
Prabhu P Raju1 insp.
Burnell M Henry1 insp.
Omotunde O Osunsanmi1 insp.
Richard H Penta1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.105(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.14(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.80(c)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Vericel Corporation's 9 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