# FDA 483 - SCL Health Front Range Inc. - March 21, 2023

Source: https://www.keypedia.com/records/483/scl-health-front-range-inc/53dc8a99-44b5-422c-a43d-401eef023b07

> FDA 483 for SCL Health Front Range Inc. on March 21, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SCL Health Front Range Inc.
- Inspection Date: 2023-03-21
- Product Type: biologics
- Office Name: Denver District Office
- Summary: SCL Front Range Inc., a blood bank in Wheat Ridge, CO, was cited for significant procedural and record-keeping deficiencies during an FDA inspection. Observations included failure to follow SOPs for blood storage temperature monitoring, lack of physician signatures for emergency transfusions, and delayed reporting of biological product deviations. These issues indicate a breakdown in quality control and record integrity for critical blood products.

## Related Officers

- [Gloria A. Milster](https://www.keypedia.com/people/gloria-a-milster/22f95276-6f68-467d-8d52-5c028c118123)

Company: https://www.keypedia.com/companies/scl-health-front-range-inc/66dbb55a-e14f-49f2-9aea-c533827bcdba

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