FDA Inspection 552605 — NYU Langone Health, Transplantation & Cellular Therapy
The FDA completed an inspection of NYU Langone Health, Transplantation & Cellular Therapy on December 31, 2008 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 31, 2008
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 208 | 21 CFR 640.3(a)(1) | Donor suitability procedures not followed |
| 3684 | 21 CFR 820.75(a) | Documentation - specific items |