FDA 483 - Blood Connection Inc. (The) - April 04, 2023

The Blood Connection Inc. (The) in Arden, NC, a donor center, was cited for failing to properly prepare phlebotomy sites. An investigator observed a phlebotomist omitting the second step of a two-step arm scrub process for multiple whole blood collections, potentially compromising the sterility of the collected units. These units were subsequently processed and made available for transport.