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

Source: https://www.keypedia.com/records/483/denver-health-medical-center/7b31d8b9-da67-4c1d-b7cc-9afa16c917e6

> 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: FDA District Office — Denver, Colorado
- Summary: An FDA inspection of Denver Health Medical Center's blood bank in Denver, CO, identified two significant observations. The firm failed to adequately validate a new computer system used for blood product management and patient testing, lacking proper documentation for its performance and approval. Additionally, deficiencies were noted in maintaining complete records for emergency blood transfusions, specifically regarding the documentation of physician signatures.

## Related Documents

- [483 - 2025-06-05](https://www.keypedia.com/records/483/denver-health-medical-center/52b0191a-31be-4df9-881e-3dca331ca692)

## 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/fda-district-office-denver-colorado/1670d160-cbfd-48fd-b9c1-fbba4631fcb0