FDA Inspection 1236679 — Utah Lions Eye Bank
The FDA completed an inspection of Utah Lions Eye Bank on Apr 23, 2024 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 23, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12325 | 21 CFR 1271.160(b)(6) | Deviations--evaluation, cause, corrective action |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |