FDA 483 - Harper University Hospital - July 01, 2025

Harper University Hospital, located in Detroit, Michigan, underwent an FDA inspection of its blood bank facilities from June 26, 2025, to July 1, 2025. The inspection identified several critical deficiencies in the facility's quality control and reporting processes. A major violation involved the hospital's failure to report significant deviations to the Center for Biologics Evaluation and Research. Specifically, between January and December 2023, the hospital irradiated numerous blood products using timer settings that fell below established safety specifications, yet failed to report these events upon discovery. Additionally, the hospital did not follow its own internal standard operating procedures for investigating such errors. Investigators also noted that equipment used for processing blood components was not standardized according to regular schedules, and required irradiation dose mapping was missed entirely in 2023. Furthermore, the facility failed to document or investigate non-conforming events and unexplained discrepancies during 2023 and 2024. These observations were issued under the regulatory framework of the Federal Food, Drug, and Cosmetic Act. Although these findings do not represent a final agency determination, the hospital is expected to respond to the FDA. The facility must outline corrective actions taken or planned to address these safety and compliance gaps to ensure the integrity of blood products intended for transfusion.