FDA 483 - Primary Children"s Hospital - Miller Campus - April 24, 2025

An FDA inspection of Primary Children's Hospital - Miller Campus in Lehi, UT, a blood bank, revealed significant deficiencies. Observations included failures in equipment validation for an X-ray irradiator and blood product refrigerators, as well as inadequate labeling for manufactured blood products. Additionally, the firm failed to submit a required biological product deviation report for a product issuance error.