FDA Inspection 730501 — Eye Bank For Sight Restoration Inc.
The FDA completed an inspection of Eye Bank For Sight Restoration Inc. on June 16, 2011 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). 8 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 16, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12288 | 21 CFR 1271.80(c) | Manufacturer instructions not followed |
| 12364 | 21 CFR 1271.195(c) | Monitoring-microorganisms where appropriate |
| 12369 | 21 CFR 1271.200(b) | Procedures inadequate |
| 12387 | 21 CFR 1271.220(a) | Causing contamination, increasing risks |
| 12399 | 21 CFR 1271.230(a) | Process validation procedures |
| 12419 | 21 CFR 1271.265(a) | Evaluation--microorganisms, damage |
| 15020 | 21 CFR 1271.200(e) | Documentation of maintenance and cleaning |