822206
NYU Langone Health, Transplantation & Cellular Therapy — FEI 2470026
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 |