FDA Inspection 846589 — Eye Bank For Sight Restoration Inc.
The FDA completed an inspection of Eye Bank For Sight Restoration Inc. on September 5, 2013 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
- September 5, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12351 | 21 CFR 1271.190(d)(1) | Procedures for cleaning, sanitation |
| 12354 | 21 CFR 1271.190(d)(2) | Documentation of activities |
| 12369 | 21 CFR 1271.200(b) | Procedures inadequate |
| 12436 | 21 CFR 1271.270(a) | Accurate, indelible, legible |
| 15020 | 21 CFR 1271.200(e) | Documentation of maintenance and cleaning |