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Optum Infusion Services 308 LLC, a compounding pharmacy in Arizona, was cited for producing sterile drug products under insanitary conditions that violated federal manufacturing standards and put patients at risk. During an inspection from March 8-18, 2022, FDA investigators documented serious deficiencies in sterile drug production practices, including failure to adequately respond to vermin observed in the production area—a known source of microbial contamination. The facility's products were found to be adulterated under the Federal Food, Drug, and Cosmetic Act because they were prepared, packed, or held under conditions where they may have become contaminated with filth or rendered injurious to health. The company received a Form FDA 483 and submitted a response in April 2022, but the deficiencies were determined to be serious enough to warrant formal enforcement action.