FDA 483 - American Red Cross Blood Services Appalachian Region - February 17, 2023

An FDA inspection of American Red Cross Blood Services Appalachian Region in Beckley, WV, from February 15-17, 2023, identified one significant observation. The firm failed to ensure proper sterile preparation of a phlebotomy site during blood collection, as a Collection Specialist did not wear gloves while scrubbing a donor's arm. This indicates a lapse in aseptic technique that could compromise blood sterility.