FDA Inspection 1260767 — Lions Medical Eye Bank & Research Center of Eastern VA
The FDA completed an inspection of Lions Medical Eye Bank & Research Center of Eastern VA on February 11, 2025 in Norfolk, VA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 11, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Norfolk, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12363 | 21 CFR 1271.195(c) | Monitoring--cross contamination, exposure to CD |
| 12415 | 21 CFR 1271.260(e) | Temperature limits |