R3 Stem Cell Responds to FDA Letter

Responding to an FDA 5/28 Notice of Violation indicating that R3 Stem Cell, Scottsdale, AZ, was promoting regenerative stem cell therapies without an approved BLA, the company says it is reviewing its Web site and operations and is unaware of any safety issues resulting from stem cell contamination. “R3 does not manufacture, package, or distribute any products,” the company statement says. “The procedures identified on R3’s Web site and discussed in the letter involve products manufactured by a tissue bank registered with FDA and subject to FDA regulation. Those products are shipped directly to licensed healthcare practitioners. R3 plays no role in the manufacture, packaging, or distribution of the product, and therefore could play no role whatsoever in any potential contamination.”

The statement says the company is undertaking a comprehensive review of its business in response to the FDA notice.