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Annovex Pharma, Inc., a registered outsourcing facility (compounding pharmacy), produced drug products that failed to meet the conditions required under section 503B of the Federal Food, Drug, and Cosmetic Act to qualify for exemptions from drug approval and labeling requirements. During an FDA inspection from August 26 to September 6, 2024, investigators identified serious deficiencies in the company's manufacturing practices that put patients at risk and determined that the compounded drugs violated the FDCA. The facility had registered as an outsourcing facility in October 2021 but failed to maintain the necessary compliance standards for this category.