FDA Inspection 754511 — Rhode Island Blood Center, A Division Of New York Blood Center, Inc. Woonsocket Donor Center
The FDA completed an inspection of Rhode Island Blood Center, A Division Of New York Blood Center, Inc. Woonsocket Donor Center on Oct 28, 2011 in Woonsocket, RI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 28, 2011
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Woonsocket, RI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 155 | 21 CFR 606.160(b) | Required records |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9220 | 21 CFR 606.100(b)(21) | Donor notification |