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

An FDA Form 483 was issued to American Red Cross Blood Services, Appalachian Region, following an inspection conducted from February 15-17, 2023, at their Beckley, WV facility. The inspection revealed an observation concerning the preparation of the phlebotomy site for blood collection. The primary issue identified was that the method used for preparing the phlebotomy site did not provide maximum assurance of a sterile collection. Specifically, an investigator observed a Collection Specialist preparing a donor's arm for a double red cell collection without wearing gloves during the skin scrubbing process. This practice raises concerns about potential contamination and the aseptic collection of blood products, which is critical for patient safety and product quality. This observation highlights the importance of strict adherence to sterile procedures as mandated by regulatory standards for blood establishments. While the FDA 483 document serves as an inspectional observation and not a final determination of compliance, it indicates practices that need immediate attention. American Red Cross Blood Services is expected to evaluate this observation, develop, and implement appropriate corrective actions to ensure all blood collection procedures consistently meet established sterility assurance protocols and regulatory requirements to prevent contamination.