In December 2019, 7 months after their initial inspection, the FDA sent a warning letter to Liveyon Labs, a major producer of umbilical cord derived tissue and other products in California, to take corrective action and become compliant with specific regulatory criteria.
The FDA determined that Liveyon Lab’s human umbilical cord blood products PURE and PURE PRO qualify as drugs, and biological products as defined by criteria set forth by the Federal Food, Drug and Cosmetic Act (FD&C) and the Public Health Service (PHS) Act. As such Liveyon Labs is required to have a valid biologics application (BLA) to market their product and an investigational new drug (IND) application to study their product which they have failed to acquire.
The FDA also determined that these products are “human cell, tissue or cellular or tissue based products (HCT/P)” and are subject to additional regulation within the PHS Act which Liveyon Labs did not meet. Furthermore, because these products are marketed to treat a variety of orthopedic conditions and are not intended to perform the same basic function of umbilical cord tissue, the FDA found they did not meet the criteria that cellular products be used for homologous use only.
The FDA concluded that due to not meeting specific regulatory criteria, not having a valid BLA, or an IND, and not qualifying for any regulatory exceptions for these products, Liveyon Labs is in violation of the FD&C Act and the PHS Act.
In addition, the FDA documented numerous deviations from current good manufacturing practice (cGMP) and current good tissue practice (cGTP) after their inspection. Deviations were found in different areas including the manufacturing processes, donor eligibility practices, aseptic practices, and environmental monitoring. The FDA stated that these deviations “pose a significant risk that your products may be contaminated with microorganisms or have other serious product quality defects.”
In response to the FDA inspection conducted in May 2019, Liveyon Labs sent the FDA a written response citing they will cease their current receipt of umbilical cord blood and take the corrective actions outlined from the inspection. However, the FDA was not satisfied with their response claiming that Liveyon Labs did not provide sufficient detail of their corrective actions or updated procedures to demonstrate these actions and did not commit to providing any follow up. The FDA was also not satisfied by Liveyon Lab’s continued failure to have an IND to study the products and continued lack of BLA to lawfully market the products.
In the warning letter sent in December 2019, the FDA requested prompt action from Liveyon Labs to correct these violations and gave them fifteen working days to respond with an outline of the specific steps they have taken or plan to take to correct the violations and prevent their recurrence. Upon receiving the warning letter from the FDA Liveyon Labs responded with this official comment;
“Liveyon has received a warning letter from the FDA regarding its cord blood-derived cellular products, PURE and PURE PRO. This warning letter was the result of an FDA inspection of Liveyon facilities in May 2019. The FDA has acknowledged Liveyon’s subsequent improvements and corrective action to date, but through this letter, requests additional corrective action, including proof of updated policies and procedures. Liveyon intends to cooperate fully with the FDA to maintain compliance in manufacturing and distribution of all of its products.”