Company
United StatesCorneaGen, LLC, Winston Salem, NC – FDA Inspections
Inspection records and compliance data for CorneaGen, LLC in Winston Salem, North Carolina. 8 FDA inspections on record, 1 Form 483, last inspected September 16, 2026.
Company Profile
This profile covers CorneaGen, LLC based in Winston Salem, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 1
- NAI
- 7
- Form 483s
- 1
- Warning letters
- 0
First inspected January 14, 2010. Last inspected September 16, 2026.
Most cited issue areas
- Monitoring--cross contamination, exposure to CD1 inspection
- Verification elements1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 16, 2026 | NAI | · Human Cellular, Tissue, and Gene Therapies | 1337312 |
| May 31, 2023 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1207713 |
| July 14, 2021 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1149011 |
| July 20, 2018 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1061992 |
| October 22, 2015 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 946041 |
| February 28, 2014 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 870037 |
| March 15, 2012 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 773966 |
| January 14, 2010 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 639145 |
FDA documents
Form 483s (1)
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Company Information
Name
CorneaGen, LLC
FEI Number
3005357288
Address
101 N Chestnut St Ste 303, Winston Salem, North Carolina 27101, United States
Country
United States
ID: 63b0f20d-2789-4c29-90c7-251cd951234a