FDA Inspection 756348 — Staten Island University Hospital Northwell Health
The FDA completed an inspection of Staten Island University Hospital Northwell Health on December 14, 2011 in Staten Island, 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
- December 14, 2011
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Staten Island, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 159 | 21 CFR 606.160(a)(1) | Legibility and indelibility |
| 85 | 21 CFR 606.100(b)(6) | Methods of component preparation |