FDA Inspection 629165 — Lions Eye Bank Of Nebraska
The FDA completed an inspection of Lions Eye Bank Of Nebraska on Nov 16, 2009 in Omaha, NE. 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
- Nov 16, 2009
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Omaha, NE (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12334 | 21 CFR 1271.170(c) | Trained or re-trained as necessary |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12396 | 21 CFR 1271.225 | Approval and timely communication |
| 12429 | 21 CFR 1271.265(d) | Shipping conditions appropriate |