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

Source: https://www.keypedia.com/records/483/primary-childrens-hospital-miller-campus/35e97b16-c1ce-4d5b-9654-e6e82e8b3716

> FDA 483 for Primary Children"s Hospital - Miller Campus on April 24, 2025. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Primary Children"s Hospital - Miller Campus
- Inspection Date: 2025-04-24
- Product Type: biologics
- Office Name: FDA District Office — Denver, Colorado
- Summary: 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.

## Related Officers

- [Emily B. Camire](https://www.keypedia.com/people/emily-b-camire/dff5f4c6-bcbe-4ef1-ac0b-1b2701b311ef)

Company: https://www.keypedia.com/companies/primary-childrens-hospital-miller-campus/1fe7d6be-33ed-4ee2-a94a-f9cf363e19b7

Office: https://www.keypedia.com/offices/fda-district-office-denver-colorado/1670d160-cbfd-48fd-b9c1-fbba4631fcb0