FDA Inspection 570121 — Overlook Medical Center - Blood Bank
The FDA completed an inspection of Overlook Medical Center - Blood Bank on March 13, 2009 in Summit, NJ. 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 13, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Summit, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 63 | 21 CFR 606.65 | Safe, sanitary, orderly storage |
| 91 | 21 CFR 606.100(b)(12) | Criteria for suitability of reissue of returned blood |
| 9220 | 21 CFR 606.100(b)(21) | Donor notification |
| 93 | 21 CFR 606.100(b)(14) | QC procedures for supplies and reagents |