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FDA Warns Companies Against Selling Unapproved Stem Cell Products

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The U.S. Food and Drug Administration warned two California-based companies for processing and distributing unapproved stem cell products that could put potentially harm patients.

The agency sent a warning letter to Liveyon Labs Inc. and Liveyon LLC, of Yorba Linda, California, as well as their presidents and chief executive officers, saying the companies significantly deviated from manufacturing practice and safety requirements.

In May, the FDA had inspected the Liveyon Labs and Liveyon LLC facility and found the companies were processing and distributing products derived from human umbilical cord blood for use in patients who were unrelated to the donors.

The companies were making and selling products that are regulated as both drugs and biological products despite not having the license to do so. The two companies' unapproved products derived from umbilical cord blood are called Pure and Pure Pro.

The FDA said the companies' deviations include deficient donor eligibility practices, inadequate aseptic practices to prevent contamination, and deficient environmental monitoring.

The companies failed to screen donors' relevant medical records for risk factors for communicable diseases, did not follow procedures to prevent microbiological contamination, and also failed to establish a system for cleaning and disinfecting the processing room as well as equipment.

According to the regulator, these deviations posed a significant risk that the products may be contaminated with viruses or other microorganisms, or have other serious product quality defects that could potentially harm patients.

The agency has sought responses from Liveyon Labs and Liveyon LLC within fifteen working days of the letter's issuance, explaining how they plan to correct the deviations noted in the warning letter. Failure to correct the deviations could lead to enforcement action such as seizure, injunction or prosecution.

In addition, the FDA has 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 twenty letters to manufacturers and health care providers saying it has noted these companies may be offering unapproved stem cell products,

Further, safety alerts have been issued by the FDA about exosome products, noting that certain clinics that also make or sell violative "stem cell" products, are now offering exosome products to patients.

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