FDA Inspection 960774 — North Shore University Hospital Northwell Health
The FDA completed an inspection of North Shore University Hospital Northwell Health on Feb 23, 2016 in Manhasset, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 23, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Manhasset, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 12280 | 21 CFR 1271.75(c) | Reproductive cells/ tissues- general |