FDA Inspection 725360 — Rhode Island Blood Center, a Division of New York Blood Center, Inc. Aquidneck Island Donor Center
The FDA completed an inspection of Rhode Island Blood Center, a Division of New York Blood Center, Inc. Aquidneck Island Donor Center on May 19, 2011 in Middletown, 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 19, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Middletown, RI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4304 | 21 CFR 211.68(b) | Written record not kept of program and validation data |
| 9044 | 21 CFR 600.10(b) | Personnel capabilities |