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Talk to a SpecialistTalk to a SpecialistJoe Wise Pharmacy, a Colorado-based compounding pharmacy, was found to have produced sterile and non-sterile drug products under insanitary conditions that violated federal manufacturing standards and put patients at risk. FDA inspectors documented serious deficiencies in the facility's design and processes, including inadequate controls for sterile compounding that resulted in products that may have become contaminated with filth or rendered injurious to health. The company voluntarily recalled all sterile drug products in July 2019 and ceased sterile compounding operations, but the violations were significant enough to warrant formal FDA enforcement action.