The US Food and Drug Administration has warned California-based Liveyon for processing and distributing unapproved products derived from umbilical cord blood, including PURE and PURE PRO.
The FDA has also warned Liveyon for deviating from the 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.
The US regulatory body has sent untitled letters to RichSource Stem Cells, and Chara Biologics, for offering unapproved stem cell products to patients.
In addition, it has sent letters to 20 manufacturers and health care providers, stating that it has come to its notice that there may be an unapproved offering of stem cell products by them.
FDA Centre for Biologics Evaluation and Research Director Peter Marks said: “The FDA’s mission includes protecting public health by helping to ensure the safety and efficacy of medical products that patients rely on.
“The agency is aware that there are establishments who prey upon vulnerable populations by commercially marketing stem cell products with false and misleading claims about their effectiveness for treating serious diseases. The FDA is taking this action today because Liveyon Labs and Liveyon LLC failed to take appropriate measures to protect patient safety.”
Liveyon deviated CGTP and CGMP requirements for PURE and PURE PRO products
The US FDA has inspected the Liveyon Labs facility in May 2019, and found that the company is processing and distributing human umbilical cord blood-based products for patients who were unrelated to the donors.
The agency has documented the evidence of certain deviations from CGTP and CGMP requirements in the company’s manufacture of PURE and PURE PRO products.
In addition, the manufacturing practices are found to be deficient of donor eligibility, and environmental monitoring, which may create critical safety concerns of putting patients in risk.
Liveyon was requested for a response within 15 working days, detailing its measures to correct the deviations noted by the FDA in its warning letter.
The FDA has also urged health care professionals and consumers to report any adverse events related to treatments with the PURE or PURE PRO products or other stem cell treatments to its MedWatch adverse event reporting program.
