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483
•Bloodworks•May 3, 2024

Bloodworks – FDA 483, May 3, 2024

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)
View Company Profile

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

Other documents for Bloodworks
  • 483 - 2025-12-11December 11, 2025

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