FDA WARNING_LETTER - Media Networks Sydney Pty Limited - July 10, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Media Networks Sydney Pty. Limited on September 16, 2025, concerning its over-the-counter (OTC) drug manufacturing operations. The company was registered with the FDA from March 6, 2024, to July 11, 2025, during which import records showed a shipment of its "Combantrin Chocolate Squares" into the United States on April 11, 2024.

The primary issues stemmed from the company"s non-compliance with the Federal Food, Drug, and Cosmetic (FD&C) Act. Specifically, Media Networks Sydney Pty. Limited failed to respond to multiple electronic requests for records and information, initiated on May 28, 2024, and continuing through April 4, 2025, under Section 704(a)(4) of the Act. Furthermore, the company refused an announced inspection on December 18, 2024, stating it had not yet begun production, a claim contradicted by U.S. import records. Refusing access to records and delaying an inspection are prohibited acts under Section 301(e) and can lead to drugs being deemed adulterated under Section 501(j) of the FD&C Act.

As a consequence, the FDA placed all drugs manufactured by the firm on Import Alert 66-79 on July 10, 2025, making them subject to detention or refusal of admission into the U.S. The company subsequently deregistered. Media Networks Sydney Pty. Limited is required to respond in writing within 15 working days, either providing information for FDA"s assessment or requesting to schedule an inspection to demonstrate compliance with quality assurance and other applicable requirements.