FDA Inspection 1050503 — Rhode Island Blood Center, a Division of New York Blood Center, Inc. Warwick Donor Center
The FDA completed an inspection of Rhode Island Blood Center, a Division of New York Blood Center, Inc. Warwick Donor Center on May 3, 2018 in Warwick, RI. 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
- May 3, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Warwick, RI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 84 | 21 CFR 606.100(b)(5) | Accurate measurement of quantity of blood |