Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistMedia Networks Sydney Pty. Limited was warned for manufacturing over-the-counter drug products, specifically Combantrin Chocolate Squares, without adequate FDA oversight and quality assurance documentation. The company failed to respond to multiple FDA records requests between May 28, 2024, and April 4, 2025, in violation of section 704(a) of the Federal Food, Drug, and Cosmetic Act, and provided contradictory statements about its manufacturing activities—initially claiming no production had occurred in Australia while import records showed drugs from the facility were shipped to the United States in April 2024. Due to these compliance failures and inability to verify quality assurance standards, the FDA placed all drugs manufactured by the company on Import Alert 66-79 on July 10, 2025, after which the firm deregistered.