# FDA 483 - Denver Health Medical Center - June 05, 2025

Source: https://www.keypedia.com/records/483/denver-health-medical-center/52b0191a-31be-4df9-881e-3dca331ca692

> FDA 483 for Denver Health Medical Center on June 05, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Denver Health Medical Center
- Inspection Date: 2025-06-05
- Product Type: biologics
- Office Name: Denver District Office
- Summary: An FDA inspection of Denver Health Medical Center's Blood Bank identified two significant observations. The firm failed to adequately validate a new computer system used for blood product management and patient testing. Additionally, the facility did not consistently maintain complete records for emergency transfusions, specifically regarding physician signatures.

## Related Officers

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

Company: https://www.keypedia.com/companies/denver-health-medical-center/2e5a6409-8f15-4522-94ea-f04088209771

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