BloodworksMay 3, 2024

FDA 483 - Bloodworks - May 03, 2024

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Record Details

An FDA inspection of Bloodworks in Seattle, WA, identified a significant deficiency in drug product component testing. The firm failed to perform specific identity tests for critical materials used in the manufacture of Cord Blood Units over several years. This indicates a lapse in quality control for essential components.

Company: Bloodworks
Inspection Date: May 3, 2024
Product Type: Biologics
Office: Division of Human and Animal Food Operations - West VI
People: Sunitha K. Rajaram (issuing_officer)
Kaarin M. Slotte (investigator)

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ID · 80a76998-4c87-4acc-b8ac-fc1e05a43565