FDA WARNING_LETTER - GenoGenix, LLC - July 18, 2025

The FDA issued a Warning Letter to GenoGenix LLC on January 20, 2026, following an inspection from July 14-18, 2025, at their Boca Raton, FL facility. The company, registered as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA), was cited for numerous serious violations. Key issues included failing to meet 503B conditions, such as using unapproved bulk drug substances (e.g., 5-Amino-1MQ, NAD+) and inadequate labeling for compounded products. The inspection also revealed significant Current Good Manufacturing Practice (CGMP) violations, leading to adulterated drug products. These included insanitary conditions in sterile production, such as operators blocking "first air" and touching product contact surfaces, along with a lack of critical quality controls like environmental monitoring, media fills, and adequate investigations. Some distributed drug products were found to be sub-potent or contained excessive bacterial endotoxins, posing patient risks. Furthermore, GenoGenix LLC introduced unapproved new drugs and biological products (e.g., Semaglutide, Tirzepatide, Thymosin Beta-4) into interstate commerce, and drug products were misbranded due to inadequate directions for use and false strength claims. The company also failed to submit required drug product reports and adverse event reports to the FDA. The FDA acknowledges the company ceased production and initiated a voluntary recall. However, current corrective actions are deemed inadequate. GenoGenix LLC must provide specific steps taken to address all violations within 15 working days, including documentation, and is strongly recommended to engage a third-party consultant for a comprehensive operational assessment if they decide to resume drug production.