FDA Inspection 920736 — CorneaGen - Orlando / Medical Eye Bank of Florida
The FDA completed an inspection of CorneaGen - Orlando / Medical Eye Bank of Florida on April 1, 2015 in Orlando, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 1, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Orlando, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12338 | 21 CFR 1271.180(b) | Review and approval-responsible person |
| 12400 | 21 CFR 1271.230(a) | Documented, dated, signed |
| 12470 | 21 CFR 1271.350(a)(2) | 15 day reporting timeframe |