The FDA warned Liveyon Labs Inc. and Liveyon LLC, as well as their top executives, for processing and distributing unapproved products derived from umbilical cord blood, according to an agency news release.
The agency sent an additional 20 letters to manufacturers and health care providers, including RichSource Stem Cells Inc. and Chara Biologics Inc., regarding unapproved stem cell products.
“The FDA’s mission includes protecting public health by helping to ensure the safety and efficacy of medical products that patients rely on,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in the release. “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.”
In May, Liveyon Labs and Liveyon LLC, of Yorba Linda, California, were found to be processing and distributing products derived from human umbilical cord blood for use in patients who were unrelated to the donors, according to findings of an FDA inspection of a Liveyon facility. Lawful marketing of these products requires an approved biologics license application, and the products cannot be used in humans without an investigational new drug application in effect, the FDA noted in its release.
Further, the FDA documented evidence of significant deviations from current good tissue practice and good manufacturing practice requirements in the manufacture of Liveyon’s PURE and PURE PRO products. Deviations included failing to screen donors’ relevant medical records for communicable diseases, inadequate aseptic practices and deficient environmental monitoring.
The FDA has requested a response from Liveyon within 15 working days that details how the deviations will be corrected. Uncorrected deviations after this time frame may result in enforcement action such as prosecution, injunction or seizure, according to the FDA.
“The FDA is taking this action today because Liveyon Labs and Liveyon LLC failed to take appropriate measures to protect patient safety,” Marks said in the release.
Disclosures: Marks is employed by the FDA.