FDA sends warning to companies for offering unapproved umbilical cord blood products that may put patients at risk
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 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.
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. 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. ,
In addition to the warning letter released, the FDA has issued a safety alert about exosome products. Certain clincs across the country, including some that also manufacture or market violative “stem cell” products, are now also offering exosome products to patients.
The FDA requested a response from Liveyon Labs and Liveyon LLC within 15 working days of the letter’s issuance that details how the deviations noted in the warning letter will be corrected. Deviations not corrected by the companies and responsible individuals could lead to enforcement action such as seizure, injunction or prosecution.