FDA Inspection 1222700 — Eye Bank For Sight Restoration Inc.
The FDA completed an inspection of Eye Bank For Sight Restoration Inc. on November 13, 2023 in New York, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 13, 2023
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12356 | 21 CFR 1271.195(a) | Adequate control, proper conditions |
| 12375 | 21 CFR 1271.210(a) | Use prior to verification |
| 12435 | 21 CFR 1271.270(a) | Records maintained concurrently |
| 12436 | 21 CFR 1271.270(a) | Accurate, indelible, legible |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |