FDA Continues Stem Cell Enforcement With New Warning Letter, Safety Notification

Regulatory NewsRegulatory News | 09 December 2019 |  By 

The US Food and Drug Administration (FDA) last week warned two California-based companies, Liveyon Labs Inc. and Liveyon LLC, for processing and distributing unapproved umbilical cord blood stem cell products.
FDA also said it warned Liveyon for “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.”
FDA also previously warned Liveyon LLC’s previous cord blood product contract manufacturer Genetech, Inc. for selling unapproved products, advising both firms of investigational new drug (IND) requirements for distributing investigational products for clinical use and biologics license application (BLA) requirements for marketing new biologics.
The warning letter follows two recent untitled letters sent to Florida-based RichSource Stem Cells and California-based Chara Biologics, advising the companies that their stem cell products do not qualify for exceptions under 21 CFR 1271.15 and appear to be intended for nonhomologous uses.
In all three letters, FDA said the unapproved products pose a significant risk of infection for patients as they are intended to be administered via injection.
In addition to the warning and untitled letters, FDA on Friday issued a public safety notification warning of “multiple recent reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes.”
FDA’s Center for Biologics Evaluation and Research Director Peter Marks signaled that more enforcement actions against stem cell companies are likely as the three-year period of enforcement discretion the agency announced in 2017 comes to an end in November 2020.
“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,” Marks said.


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy