San Juan Capistrano, CA-based stem cell clinic Stemell, Inc was warned by the US Food and Drug Administration (FDA) over its sale of unapproved umbilical cord products and for good tissue practice (GTP) and good manufacturing practice (GMP) violations, followed by a weeklong inspection in March.
Acting FDA Commissioner Ned Sharpless said, “Those who manufacture or market unapproved, potentially unsafe products should understand that there is a clear line between development of these products and those practices that sidestep important statutory and regulatory controls that are in place to protect patients.”
Besides the warning letter to Stemell, FDA reported that it sent an additional 20 letters to manufacturers and clinics offering unapproved stem cell products notifying them of the agency’s compliance and enforcement policies for human cells, tissues, and cellular and tissue-based products (HCT/Ps).
According to the warning letter, Stemell manufactures and markets two stem cell-based products, StemL UCB-Plus and StemL UCT-Plus, for allogenic use that do not qualify for exceptions for HCT/Ps, set out in 21 CFR 1271.15 as they are not intended for homologous use.