On December 6, 2019, the FDA warned Liveyon Labs Inc. (“Liveyon Labs”) and Liveyon LLC for processing and distributing unapproved products derived from umbilical cord blood (PURE and PURE PRO). The FDA further warned the companies 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. The FDA warned that these deviations create potential significant safety concerns that put patients at risk.
An FDA inspection of the Liveyon Labs and Liveyon LLC facility in May 2019 revealed they 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 May 2019 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. The FDA states that 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 patient harm.
The FDA also sent warning letters to RichSource Stem Cells, Inc. and Chara Biologics, Inc., for offering unapproved stem cell products to patients, as well as 20 letters to manufacturers and health care providers that may be offering unapproved stem cell products.
The Director of the FDA’s Center for Biologics Evaluation and Research stated, “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.”
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