FDA 483 - Carolina Conceptions, PA - June 01, 2023

Carolina Conceptions, PA in Raleigh, NC, received a Form FDA 483 for failing to properly determine HCT/P donor eligibility. The firm determined three donors eligible without completing all required screening and testing, including HIV/HCV/HBV NAT. Additionally, HCT/Ps from ineligible donors made available for limited use were not prominently labeled with the required communicable disease risk warning statement.