Federal regulators have told a Scottsdale, Arizona company that the umbilical cord products it manufactures and sells to clinics are unapproved drugs and unlicensed biological products, and that inspectors found the company never validated whether it could make them sterile. The warning letter to R3 Medical Companies and its chief executive, Dr. David L. Greene, was issued by the FDA's Center for Biologics Evaluation and Research on Aug. 14 and posted publicly on Aug. 25.
The letter matters beyond one firm because of where the products went. According to the letter, Greene is also chief executive of affiliated R3 Anti-Aging clinics in Brentwood, Tennessee, and Beverly Hills, California, alongside the Scottsdale operation. Products reached those three clinics, other health care professionals, and additional clinics through a partner program.
