FDA Inspection 611083 — San Diego Eye Bank
The FDA completed an inspection of San Diego Eye Bank on Sep 8, 2009 in San Diego, 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). 8 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 8, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |
| 12311 | 21 CFR 1271.160(b)(1) | Ensuring appropriate core requirements followed |
| 12325 | 21 CFR 1271.160(b)(6) | Deviations--evaluation, cause, corrective action |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12399 | 21 CFR 1271.230(a) | Process validation procedures |
| 12429 | 21 CFR 1271.265(d) | Shipping conditions appropriate |
| 12433 | 21 CFR 1271.265(f) | Return to inventory--procedures |
| 12457 | 21 CFR 1271.320(a) | Procedures re complaints |