# FDA 483 - Lucina BioSciences, LLC - August 10, 2021

Source: https://www.globalkeysolutions.net/records/483/lucina-biosciences-llc/963557cd-541d-4862-987f-909b662212fe

> FDA 483 for Lucina BioSciences, LLC on August 10, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lucina BioSciences, LLC
- Inspection Date: 2021-08-10
- Product Type: biologics
- Office Name: Denver District Office
- Summary: Lucina BioSciences, LLC in Aurora, CO, an HCT/P processor, was cited for significant deficiencies during an FDA inspection. Observations included failure to adequately screen HCT/P donors for communicable disease risk factors, inadequate environmental monitoring for microorganisms during processing, and insufficient record-keeping for processing steps and personnel. These issues indicate a lack of control over critical aspects of HCT/P manufacturing and donor eligibility.

## Related Officers

- [Travis S. Bradley](https://www.globalkeysolutions.net/people/travis-s-bradley/4d7756cb-65fd-4bd6-be24-25710668e6d8)

Company: https://www.globalkeysolutions.net/companies/lucina-biosciences-llc/fc4717fd-218b-44ce-a6e4-c87aace6ba87

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