FDA Inspection 1109451 — 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 November 12, 2019 in Hyattsville, MD. 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
- November 12, 2019
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Hyattsville, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |