FDA Inspection 1174916 — North Shore University Hospital Northwell Health
The FDA completed an inspection of North Shore University Hospital Northwell Health on July 20, 2022 in Manhasset, 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
- July 20, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Manhasset, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |