California Company, Stemell, Receives Warning Letter

September 6, 2019

FDA sent a warning letter to Stemell, Inc. for manufacturing and distributing unapproved products derived from umbilical cord blood and umbilical cord and for significant deviations from current good tissue practice and current good manufacturing practices.

FDA sent a warning letter, dated Aug. 28, 2019, to Stemell, Inc. (Stemell), of San Juan Capistrano, California for manufacturing and distributing unapproved products derived from umbilical cord blood and umbilical cord and for significant deviations from current good tissue practice and current good manufacturing practices. According to FDA, the company engaged in deficient donor eligibility practices and environmental monitoring, “creating potential significant safety concerns that put patients at risk.”

During an inspection conducted in March 2019, the agency found the company was manufacturing products derived from human umbilical cord blood and umbilical cord and using the products in recipients unrelated to the donors. FDA states these products require an approved biologics license application and may only be used in humans if there is an investigational new drug application in effect, which they do not have. Inspectors also observed deficient donor eligibility practices, unvalidated manufacturing processes, deficient environmental monitoring, and inadequate aseptic processes.

“We know that there are manufacturers and clinics across the country that manufacture or market violative stem cell products to patients, claiming that they don't fall under the regulatory provisions for drugs and biological products. The FDA has consistently stated that this is not true,” said Acting FDA Commissioner Ned Sharpless, MD, in a statement. “This company failed to take appropriate measures to protect patient safety. The FDA will be increasing our oversight related to cell-based regenerative medicine as part of our comprehensive plan to promote beneficial innovation while protecting patients. Those who are manufacturing or marketing unapproved, potentially unsafe products must understand that there’s a clear line between appropriate development of these products and those practices that sidestep important statutory and regulatory controls that are in place to protect patients.”

Source: FDA