FDA sends warning to companies for offering unapproved umbilical cord blood products that may put patients at risk | FDA

FDA sends warning to companies for offering unapproved umbilical cord blood products that may put patients at risk | FDA

FDA sends warning to companies for offering unapproved umbilical cord blood products that may put patients at risk

Liveyon Labs Inc. and Liveyon LLC warned that their stem cell products lack required FDA approval and represent a potential risk to the public health

The U.S. Food and Drug Administration has warned Liveyon Labs Inc. (Liveyon Labs) and Liveyon LLC, of Yorba Linda, California, and their presidents and chief executive officers, Roya Panah and John W. Kosolcharoen, for processing and distributing unapproved products derived  from umbilical cord blood. They have also been warned regarding significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, including deficient donor eligibility practices, inadequate aseptic practices to prevent contamination and deficient environmental monitoring. These deviations create potential significant safety concerns that ...

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