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Southern Tier Home Infusion, Inc. dba Pharmacy Innovations, a compounding pharmacy in Erie, Pennsylvania, was cited for producing adulterated sterile drug products that failed to meet exemption requirements under Federal Food, Drug, and Cosmetic Act Section 503A. FDA inspectors (November 2022) identified serious deficiencies in the company's sterile compounding practices, including use of a non-hazardous ISO 5 classified laminar air flow workbench for sterile product production, which created patient safety risks. The company voluntarily recalled all sterile compounded products manufactured between October 2 and November 30, 2022, and subsequently ceased sterile production in the deficient equipment.