483
Primary Children"s Hospital - Miller CampusFDA 483 - Primary Children"s Hospital - Miller Campus - April 24, 2025
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Record Details
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.
- Inspection Date
- April 24, 2025
- Product Type
- Biologics
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