(RxWiki News) A United States company is under fire for selling unapproved umbilical cord products.
The US Food and Drug Administration (FDA) has issued a warning to the California company Stemell, Inc., for selling unapproved umbilical cord products, including umbilical cord blood.
The FDA said these unapproved products may place consumers at risk. The agency continues to warn patients of the risk of buying and using unapproved stem cell therapy products.
According to the FDA, Stemell was not following the necessary manufacturing requirements when making the products in question.
The products listed in the FDA's recent warning were StemL UCB-Plus and StemL UCT-Plus.
Here's what the FDA found in its inspection of these Stemell products:
- The company was making products for people who were unrelated to the donors of the products.
- The products were not being used to perform the same function in the recipient as in the donor.
- The products failed to meet criteria set by FDA regulations.
- The company was not following the required manufacturing process to ensure the products are not contaminated.
The FDA said Stemell does not have the licenses or applications necessary to safely offer these products on the market.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, noted in a press release that the FDA had issued letters to 20 US manufacturers and health care providers who may have been selling unapproved stem cell products.
The FDA urged consumers to report any adverse events tied to products made by Stemell, as well as other stem cell treatments. These adverse events can be reported to the FDA's MedWatch Adverse Event Reporting program.
Ask your health care provider any questions you have about these or similar products.
Written by Anyssa Garza, PharmD, BCMAS