483
Rhode Island Blood Center, a Division of New York Blood Center, Inc., Westerly Donor CenterFDA 483 - Rhode Island Blood Center, a Division of New York Blood Center, Inc., Westerly Donor Center - April 15, 2022
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
The FDA inspected the Rhode Island Blood Center, Westerly Donor Center, and issued a Form 483 with two observations. The inspection revealed failures in determining donor health, specifically regarding the assessment of phlebotomy sites for inflammation and the examination for signs of injected drug use. These issues indicate deficiencies in donor screening procedures.
- Inspection Date
- April 15, 2022
- Product Type
- Biologics
- Person
Open in Dashboard
ID · 3f787d5e-455d-4355-9b13-7d2546b81b9a