Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistAnazaoHealth Corporation, a Las Vegas-based outsourcing facility registered to compound sterile drugs, produced drug products that failed to meet the conditions required under FDA section 503B to qualify for exemptions from drug approval and labeling requirements. During an FDA inspection conducted September 9-19, 2019, investigators documented that the company's compounded drug products violated the Federal Food, Drug, and Cosmetic Act by not maintaining compliance with outsourcing facility standards necessary for regulatory exemptions. The company received a Form FDA 483 on September 19, 2019, and provided responses through October 2020, but the violations remained unresolved.