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MedisourceRx, an outsourcing facility registered to compound sterile drugs, failed to meet the conditions required under section 503B of the Federal Food, Drug, and Cosmetic Act during an FDA inspection conducted from May 27 to June 10, 2025. The inspection found that drug products produced by the facility violated the FDCA and did not qualify for exemptions from drug approval requirements, adequate labeling requirements, and Drug Supply Chain Security Act provisions that outsourcing facilities are permitted under the law. The facility received a Form FDA 483 on June 10, 2025, and submitted responses on July 2, September 5, and October 10, 2025, but the violations were not adequately resolved.