FDA Inspection 1250142 — NYU Langone Health, Transplantation & Cellular Therapy
The FDA completed an inspection of NYU Langone Health, Transplantation & Cellular Therapy on September 26, 2024 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 26, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 142 | 21 CFR 606.140(a) | Establishment of spec., standards, and test procedures |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |