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Stokes Healthcare Inc. dba Epicur Pharma, an outsourcing facility registered to compound sterile drugs under FDA section 503B, produced adulterated drug products that failed to meet the conditions required for compounding exemptions from drug approval requirements. During a September-October 2023 inspection, FDA investigators identified serious deficiencies in the company's practices for producing sterile drug products that put patients at risk and determined the facility's products violated the Federal Food, Drug, and Cosmetic Act. The company received a Form FDA 483 on October 25, 2023, and submitted a response on November 15, 2023, but the violations were significant enough to warrant the warning letter issued April 2, 2024.