FDA 483 - Vitalant - May 15, 2019

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 The firm did not adequately assess a whole blood donor's travel history to malaria-endemic areas, using an outdated reference document and failing to properly document or search for travel locations.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.