FDA Inspection 1197940 — 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 16, 2023 in Norfolk, VA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 16, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Norfolk, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12324 | 21 CFR 1271.160(b)(6) | Deviations--Investigation, documenting, trending |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12369 | 21 CFR 1271.200(b) | Procedures inadequate |
| 12395 | 21 CFR 1271.225 | Verification/validation |