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GenoGenix LLC, an outsourcing facility registered to compound drugs, failed to meet the conditions required under section 503B of the Federal Food, Drug, and Cosmetic Act, with FDA investigators documenting serious deficiencies in drug production practices that put patients at risk during a July 2025 inspection. The facility produced drug products intended to be sterile that lacked sterility assurance and were contaminated with microorganisms, leading the company to voluntarily recall affected products on July 30, 2025. GenoGenix subsequently ceased all drug production and distribution operations and submitted responses to FDA's Form FDA 483 findings between August and November 2025.