FDA Inspection 829353 — Cooperman Barnabas Medical Center Inc.
The FDA completed an inspection of Cooperman Barnabas Medical Center Inc. on April 29, 2013 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
- April 29, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Livingston, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 94 | 21 CFR 606.100(b)(15) | Schedules and procedures for equipment & calibration |