The U.S. Food and Drug Administration (FDA) 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 put patients at risk. The companies’ unapproved products derived from umbilical cord blood are PURE and PURE PRO.
In addition to the warning letter issued to Liveyon Labs and Liveyon LLC earlier this month, the FDA sent untitled letters to RichSource Stem Cells, Inc., and Chara Biologics, Inc., for offering unapproved stem cell products to patients. The agency also recently sent 20 letters to manufacturers and health care providers noting that it has come to our attention that they may be offering unapproved stem cell products, reiterating the FDA’s compliance and enforcement policy.
"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," said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. "The FDA is taking this action today because Liveyon Labs and Liveyon LLC failed to take appropriate measures to protect patient safety. As evidenced by the number of actions that the agency has taken this month alone, there are still many companies that have failed to come into compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s regulations during the period in which the agency intends to exercise enforcement discretion for certain products with respect to FDA’s investigational new drug and premarket approval requirements, when the use of the product does not raise reported safety concerns or potential significant safety concerns. This period, which ends in November 2020, has allowed product manufacturers time to engage with the FDA to determine if they need to submit a marketing authorization application and, if so, seek guidance on how to submit their application to the FDA for approval. The agency continues to urge these manufacturers to engage with the agency about their regulatory requirements in the coming months."
An FDA inspection of the Liveyon Labs and Liveyon LLC facility in May revealed the companies were processing and distributing products derived from human umbilical cord blood for use in patients who were unrelated to the donors. Because these products are not intended for homologous use only (i.e., to perform the same basic function or functions in the recipient as in the donor) and fail to meet other criteria set forth in applicable FDA regulations, they are regulated as both drugs and biological products. Therefore, to lawfully market these products, an approved biologics license application is needed. While in the development stage, the products may be used in humans only if an investigational new drug application (IND) is in effect. However, no such licenses or INDs exist for the PURE and PURE PRO products marketed by Liveyon Labs and Liveyon LLC.
During the inspection, the FDA documented evidence of significant deviations from CGTP and CGMP requirements in the manufacture of the PURE and PURE PRO products, including deficient donor eligibility practices, such as failing to screen donors’ relevant medical records for risk factors for communicable diseases; inadequate aseptic practices, such as failing to follow procedures to prevent microbiological contamination; and deficient environmental monitoring, such as failing to establish a system for cleaning and disinfecting the processing room and equipment. These deviations pose a significant risk that the products may be contaminated with viruses or other microorganisms or have other serious product quality defects, which could potentially lead to pa...
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