Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistFarmakeio Outsourcing LLC, a registered outsourcing facility in Southlake, Texas, produced compounded drug products that failed to meet the conditions required under section 503B of the Federal Food, Drug, and Cosmetic Act necessary to qualify for exemptions from drug approval and labeling requirements. During an FDA inspection conducted from October 22-30, 2019, investigators identified that the facility's compounded sterile drugs did not comply with applicable FDCA provisions, resulting in the issuance of a Form FDA 483. The company's response to the inspection findings, submitted on November 4, 2019, was acknowledged but did not resolve the underlying violations that rendered the products adulterated under federal law.