FDA Inspection 1167109 — Rhode Island Blood Center, a Division of New York Blood Center, Inc., Westerly Donor Center
The FDA completed an inspection of Rhode Island Blood Center, a Division of New York Blood Center, Inc., Westerly Donor Center on April 15, 2022 in Westerly, 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
- April 15, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Westerly, RI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18091 | 21 CFR 630.10(f)(6)(i) | Physical Assessment Determination - Phlebotomy site |
| 18092 | 21 CFR 630.10(f)(6)(ii) | Physical Assessment Determination - Skin Examination |