FDA 483 - ARUP Laboratories, Inc. - November 06, 2024

ARUP Laboratories, Inc. in Sandy, UT, a blood bank, was issued a Form 483 following an FDA inspection that identified significant deficiencies. The firm failed to adequately test a new system, leading to critical errors such as donors incorrectly registering for platelets and an employee having unauthorized permissions to process donations. These issues indicate a lack of robust system validation and quality control impacting donor management and donation integrity.