FDA EIR - ARUP Laboratories, Inc. - March 11, 2019

An FDA inspection of ARUP Laboratories, Inc.'s donor center in Salt Lake City, UT, was conducted from March 8 to March 11, 2019, as part of the Office of Biological Product Operations workplan (Compliance Program 7342.001). The inspection assessed Quality Assurance, Donor Eligibility, and Production and Processing systems for whole blood and apheresis collections. Although no FDA-483 was issued, three notable issues were discussed with facility management. Firstly, the informed consenting process for apheresis donors was deemed ineffective; specifically, the risks and hazards of plateletpheresis were not verbally explained to donors annually as mandated by 21 CFR 640.21(g), and donors were observed signing consent without thorough review. Management committed to revising procedures to ensure annual verbal explanations and proper donor engagement with consent forms. Secondly, the firm failed to obtain a postal address where donors could be contacted for eight weeks post-donation, which is required under 21 CFR 630.10(g)(1). ARUP management promptly added a question to their donor questionnaire to address this. Lastly, during whole blood collections, donor specialists improperly placed sterile gauze on the donorase shoulder before the venipuncture site, which could compromise sterility. Management agreed to reinforce proper sterile technique among staff. The company demonstrated a commitment to addressing the identified practices.