FDA Inspection 1152947 — CorneaGen LLC
The FDA completed an inspection of CorneaGen LLC on September 24, 2021 in Seattle, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 24, 2021
- Fiscal Year
- 2021
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Seattle, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12240 | 21 CFR 1271.55(b)(3) | Name and address on summary |