Biotek America, LLC/dba Freedom Plasma

FDA 483 - Biotek America, LLC/dba Freedom Plasma

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Biotek America, LLC/dba Freedom Plasma in Paducah, Kentucky, received a Form 483 with two observations following an inspection of its plasmapheresis center. The firm was cited for requiring donors to sign an arbitration agreement containing exculpatory language that waives legal rights, and for implementing a major change to its informed consent process via video without prior FDA approval, which also failed to adequately explain risks to donors.

Company: Biotek America, LLC/dba Freedom Plasma
Product Type: Biologics
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Michelle D. Gutierrez

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ID · f8b3cbe7-e0eb-4ac2-a339-e161de7cd6be