FDA 483 - Vitalant - May 15, 2019
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An FDA inspection of BloodSource, Inc. in Placerville, CA, conducted from May 14-15, 2019, revealed a significant failure in determining donor eligibility. The firm did not adequately assess a whole blood donor's travel history to malaria-endemic areas, using an outdated reference document and failing to properly document or search for travel locations. This lapse indicates a critical procedural deficiency in preventing the collection of potentially contaminated blood.
ID · 6a55d708-5ff0-4d57-ad48-946f145f69a3