FDA Inspection 778382 — Utah Lions Eye Bank
The FDA completed an inspection of Utah Lions Eye Bank on Apr 6, 2012 in Salt Lake City, UT. 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 6, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12226 | 21 CFR 1271.47(d) | Determining risks when departures involved |
| 12453 | 21 CFR 1271.290(e) | Documenting disposition of each HCT/P |