FDA Inspection 729194 — CorneaGen - Richmond
The FDA completed an inspection of CorneaGen - Richmond on Jun 13, 2011 in Richmond, 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). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 13, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Richmond, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12244 | 21 CFR 1271.55(d)(1)(i) | Documentation of CD testing and labs |