FDA Inspection 649252 — Staten Island University Hospital Northwell Health
The FDA completed an inspection of Staten Island University Hospital Northwell Health on March 4, 2010 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 4, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Staten Island, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 4412 | 21 CFR 211.194(a)(7) | Signatures and dates--person who performs test |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |