FDA Inspection 964016 — Blood Bank Of Delmarva, a Division of New York Blood Center, Inc.
The FDA completed an inspection of Blood Bank Of Delmarva, a Division of New York Blood Center, Inc. on February 2, 2016 in Newark, DE. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 2, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Newark, DE (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9086 | 21 CFR 600.14(a)(1) | Who must report - manufacturer |
| 9089 | 21 CFR 600.14(c) | When to report |
| 9282 | 21 CFR 640.15(a) | Accompanying unit |
| 98 | 21 CFR 606.100(c) | Thorough investigations |