Invitrx Draws Warning Letter for Unapproved Products

The FDA has issued a warning letter to a Lake Forest, Calif.-based biologics company, Invitrx Therapeutics, for selling unapproved allogenic cellular-derived drugs, including a human umbilical cord-derived product.

The FDA said that the company’s Invitra UC-MSC is a human cell, tissue, or cellular or tissue-based product that is intended to treat orthopedic conditions, such as osteoarthritis, and therefore does not fall under the homologous-use exemption and must be regulated as a drug product.

Likewise, the agency said the company’s Invitra EX and Invitra EV-OP exosome products (exosomes carry genetic information and proteins to cells) are marketed for treating diseases and do not have an approved investigational new drug or biologics license application.

The FDA previously issued a public safety notification after multiple reports of serious side effects from these exosome products. This latest FDA warning letter follows a previous warning in March 2020 in which the FDA chastised the company for selling the unapproved products and violating current good manufacturing practices.