FDA Inspection 977565 — CorneaGen, LLC
The FDA completed an inspection of CorneaGen, LLC on June 15, 2016 in South San Francisco, CA. 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
- June 15, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- South San Francisco, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12356 | 21 CFR 1271.195(a) | Adequate control, proper conditions |