FDA Warns Stemell for Unapproved Stem Cell Products

The FDA hit California-based stem cell company Stemell with a warning letter for deviations from current good tissue practices and current good manufacturing practices.

The agency found the company’s StemL UCB-Plus and StemL UCT-Plus to be unapproved drugs derived from umbilical-cord blood and umbilical-cord.

The FDA inspected the San Juan Capistrano facility in March and found deficient donor eligibility practices, unvalidated manufacturing processes, deficient environmental monitoring and inadequate aseptic processes.