FDA Inspection 1176014 — CorneaGen, LLC
The FDA completed an inspection of CorneaGen, LLC on Jul 29, 2022 in South San Francisco, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 29, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- South San Francisco, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12363 | 21 CFR 1271.195(c) | Monitoring--cross contamination, exposure to CD |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |