Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-10.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Sep 2025 – 10 Sep 2025 | Biologics | Clean | |
| 18 Jul 2022 – 29 Jul 2022 | Biologics | 483 | View 483 → |
| 26 Feb 2018 – 27 Feb 2018 | Biologics | Clean | |
| 13 Jun 2016 – 15 Jun 2016 | Biologics | 483 | View 483 → |
| 12 Jun 2013 – 17 Jun 2013 | Biologics | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Jul 2022
21 CFR 1271.195(c)
Monitoring--cross contamination, exposure to CD
Cited by Shelley H Beausoleil, Ka L Wong
29 Jul 2022
21 CFR 1271.230(a)
Validation & approval--established procedures
Cited by Shelley H Beausoleil, Ka L Wong
Investigators
FDA investigators tied to this site in the record.
Shelley H Beausoleil2 insp.
Ka L Wong1 insp.
Kip J Hanks1 insp.
Bryce A May1 insp.
Peter S Kessler1 insp.
Laverne Puckett1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.195(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 |
Full site report
Get the verbatim findings behind CorneaGen, LLC's 2 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