FDA Inspection 746748 — Cooperman Barnabas Medical Center Inc.
The FDA completed an inspection of Cooperman Barnabas Medical Center Inc. on Sep 28, 2011 in Livingston, NJ. 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 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 |