FDA Inspection 822206 — NYU Langone Health, Transplantation & Cellular Therapy
The FDA completed an inspection of NYU Langone Health, Transplantation & Cellular Therapy on March 25, 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). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 25, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 144 | 21 CFR 606.140(c) | Adequate identification and handling of test samples |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 1879 | 21 CFR 211.180(c) | Records not made readily available to FDA |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9225 | 21 CFR 606.171 | Biological product deviation report |