Company
United StatesCorneaGen, Baltimore, MD – FDA Inspections
Inspection records and compliance data for CorneaGen in Baltimore, Maryland. 8 FDA inspections on record, last inspected September 22, 2026.
Company Profile
This profile covers CorneaGen based in Baltimore, Maryland, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 0
- NAI
- 8
- Form 483s
- 0
- Warning letters
- 0
First inspected January 21, 2010. Last inspected September 22, 2026.
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 22, 2026 | NAI | · Human Cellular, Tissue, and Gene Therapies | 1338912 |
| September 15, 2021 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1153003 |
| September 14, 2018 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1068567 |
| August 22, 2016 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 981338 |
| March 25, 2014 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 872226 |
| November 16, 2012 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 807888 |
| June 9, 2010 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 666742 |
| January 21, 2010 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 638570 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
CorneaGen
FEI Number
3001236461
Address
5520 Research Park Dr Ste 400, Baltimore, Maryland 21228, United States
Country
United States
ID: 9df61303-9794-4f51-935f-2f9a2bfe1945