483
Primary Children"s Hospital - Miller CampusPrimary Children"s Hospital - Miller Campus – FDA 483, Apr 24, 2025
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
- Office
- Denver District Office
- Person
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ID · 35e97b16-c1ce-4d5b-9654-e6e82e8b3716
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