FDA Inspection 672042 — San Diego Eye Bank
The FDA completed an inspection of San Diego Eye Bank on Jul 21, 2010 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 21, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12323 | 21 CFR 1271.160(b)(5) | Monitoring systems |
| 12326 | 21 CFR 1271.160(c) | Quality audits performed periodically |
| 12364 | 21 CFR 1271.195(c) | Monitoring-microorganisms where appropriate |
| 12399 | 21 CFR 1271.230(a) | Process validation procedures |