FDA inspection
CorneaGen, LLC: FDA inspection ending May 31, 2023
FDA inspection 1207713 · Voluntary Action Indicated (VAI) · Winston Salem, NC
Key facts
| Inspection ID | 1207713 |
|---|---|
| Firm | CorneaGen, LLC |
| FEI number | 3005357288 |
| Address | 101 N Chestnut St Ste 303 |
| City | Winston Salem |
| State | NC |
| ZIP | 27101 |
| Country | United States |
| Fiscal year | 2023 |
| Inspection end date | May 31, 2023 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Blood and Blood Products |
| Product type | Biologics |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data