483
BloodworksBloodworks – 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.
View Company Profile
ID · 80a76998-4c87-4acc-b8ac-fc1e05a43565
Other documents for Bloodworks
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.