logo
Plus   Neg
Share
Email

FDA Warns Companies Against Selling Unapproved Stem Cell Products

fda-dec09-lt.jpg

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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Swiss drug major Novartis AG reported Wednesday that its fourth-quarter net profit declined, while operating income climbed on strong sales growth. Looking ahead, for fiscal 2020, the company expects net sales to grow mid to high-single digit and core operating income to grow high-single to low double digit, both in constant currency. Starbucks on Tuesday said it has closed more than half of its stores in China temporarily due to the worsening coronavirus outbreak that claimed around 132 lives in the country. The coffee giant is also monitoring and modifying the operating hours of all of its stores in the region.The closed store count would be more than 2000 as Starbucks operates almost 4,300 outlets in China. eBay Inc. (EBAY) Wednesday reported a fourth-quarter profit that trumped Wall Street analysts' estimates, as did revenues. However, shares of the company slipped over 5% after the company issued a weak outlook for the first quarter. eBay's fourth-quarter profit dropped to $558 million or $0.69 per...
Follow RTT
>