FDA warns company for selling unapproved umbilical cord blood and umbilical cord products
The FDA has warned Stemell, Inc. (Stemell), of San Juan Capistrano, California, and its president and Chief Executive Officer, Peyman Taeidi, PhD, for manufacturing and distributing unapproved products derived from umbilical cord blood and umbilical cord and for significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, including deficient donor eligibility practices and environmental monitoring, creating potential significant safety concerns that put patients at risk. Stemell’s unapproved products derived from umbilical cord blood and umbilical cord are StemL UCB-Plus and StemL UCT-Plus.
The FDA’s recent inspection of the Stemell facility in March revealed that the company was manufacturing products derived from human umbilical cord blood and umbilical cord for use in recipients unrelated to the donors of the products. Because these Stemell products are not intended for homologous use only (i.e., to perform the same basic function or functions in the recipient as in the donor) and fail to meet other criteria set forth in applicable FDA regulations, they are regulated as both drugs and biological products. To lawfully market these products, an approved biologics license application is needed. While in the development stage, the products may be used in humans only if an investigational new drug application (IND) is in effect. However, no such licenses or INDs exist for these Stemell products.
During the inspection, the FDA documented evidence of significant deviations from CGTP and CGMP requirements in the manufacture of Stemell’s products, including deficient donor eligibility practices, unvalidated manufacturing processes, deficient environmental monitoring and inadequate aseptic processes. These deviations pose a risk that the products may be contaminated with viruses or microorganisms or have other serious product quality defects.
The FDA requested a response from Stemell, within 15 working days of the letter’s issuance, that details how the deviations noted in the warning letter will be corrected. Deviations not corrected by companies and owners could lead to enforcement action such as seizure, injunction or prosecution.
