FDA Inspection 746748 — Cooperman Barnabas Medical Center Inc.
The FDA completed an inspection of Cooperman Barnabas Medical Center Inc. on September 28, 2011 in Livingston, 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
- September 28, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Livingston, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |