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Staska Pharmaceuticals, Inc., an outsourcing facility registered to compound sterile drugs, produced drug products that failed to meet the conditions required under section 503B of the Federal Food, Drug, and Cosmetic Act and violated federal regulations. During a September 2024 inspection, FDA investigators identified serious deficiencies in the company's practices for producing sterile drug products that put patients at risk, including a voluntary recall initiated in September 2024 for Ascorbic Acid Solution for Injection due to glass particulates. The facility's compounded drugs did not qualify for exemptions from drug approval requirements because they failed to comply with applicable FDCA provisions governing outsourcing facilities.