FDA Inspection 717902 — Robert Wood Johnson University Hospital Somerset
The FDA completed an inspection of Robert Wood Johnson University Hospital Somerset on April 14, 2011 in Somerville, NJ. 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
- April 14, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Somerville, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 9225 | 21 CFR 606.171 | Biological product deviation report |
| 93 | 21 CFR 606.100(b)(14) | QC procedures for supplies and reagents |