FDA Inspection 774676 — San Antonio Eye Bank
The FDA completed an inspection of San Antonio Eye Bank on Mar 29, 2012 in San Antonio, TX. 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 29, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- San Antonio, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12375 | 21 CFR 1271.210(a) | Use prior to verification |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |