FDA 483 - Rhode Island Blood Center, a Division of New York Blood Center, Inc., Westerly Donor Center - April 15, 2022

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.