FDA 483 - Biomat USA Inc

BioTek America, LLC, a plasmapheresis center in Louisville, Kentucky, was inspected by the FDA from February 28 to March 2, 2023. The inspection revealed that the firm failed to include all required information in the notification and counseling messages provided to donors deferred due to reactive test results for transfusion-transmitted diseases. This deficiency impacts the clarity of deferral status and the completeness of test results provided to affected donors.