# FDA 483 - Primary Children's Hospital - April 17, 2025

Source: https://www.keypedia.com/records/483/primary-childrens-hospital/c7ffda6a-4a0d-4e38-b318-c6a1bbef4ddc

> FDA 483 for Primary Children's Hospital on April 17, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Primary Children's Hospital
- Inspection Date: 2025-04-17
- Product Type: biologics
- Office Name: Denver District Office
- Summary: Primary Children's Hospital in Salt Lake City, UT, was inspected by the FDA from April 15-17, 2025. The inspection revealed a significant issue regarding the maintenance of records for emergency blood transfusions. Specifically, the hospital failed to obtain physician signatures for emergency-released blood products that were subsequently returned untransfused, indicating a lapse in critical record-keeping practices.

## Related Officers

- [Melissa S. Mcguinness](https://www.keypedia.com/people/melissa-s-mcguinness/5a7054ba-be7b-488a-a244-294b85c33d0b)
- [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/c5e47623-6dfa-48f9-9719-c1e2a1fd1585

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face