FDA EIR - American Red Cross Blood Services - July 27, 2020

An FDA Level 2 inspection was conducted at American Red Cross Blood Services in Farmington, CT, from July 22-27, 2020. This routine inspection, part of the Office of Biological Products Operations' FY2020 workplan and aligned with the "Inspection of Licensed and Unlicensed Blood Banks program" (CP 7342.001), evaluated the licensed blood establishment's compliance with regulatory standards. The inspection covered critical systems including Donor Eligibility/Suitability, Product Collection, Component Preparation, and Quality Assurance. Detailed reviews were performed on operations such as whole blood and apheresis donations, manufacturing processes for red blood cells and plasma, irradiation, donor deferrals, product complaints, recalls, and equipment management. The facility collects allogeneic, directed, and autologous whole blood, as well as apheresis platelet and plasma products, utilizing both fixed and mobile donor sites. Significantly, the inspection concluded with no deficiencies or objectionable conditions identified. Consequently, no Form FDA 483, Inspectional Observation, was issued, indicating the company's full compliance with regulatory requirements at the time of the inspection. Management was reminded of their ongoing responsibility to adhere to all applicable laws and regulations governing blood services.