FDA Inspection 1085833 — Lions Eye Bank For Long Island
The FDA completed an inspection of Lions Eye Bank For Long Island on April 10, 2019 in Valley Stream, NY. 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
- April 10, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Valley Stream, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12369 | 21 CFR 1271.200(b) | Procedures inadequate |
| 12433 | 21 CFR 1271.265(f) | Return to inventory--procedures |
| 12436 | 21 CFR 1271.270(a) | Accurate, indelible, legible |