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Warning Letter 320-25-110

September 16, 2025

Dear Mr. Wielunski:

Your facility was registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products from March 6, 2024, to July 11, 2025.

A review of import records showed a shipment of the OTC drug product, Combantrin Chocolate Squares, into the United States on April 11, 2024, which declared Media Networks Sydney Pty. Limited as the drug manufacturer.

On May 28, 2024, the FDA sent an electronic request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 374(a)(4), to the contact e-mail address provided in your registration file. This request went unanswered as did numerous follow-up requests made between May 28, 2024, and April 4, 2025.

It is a prohibited act under section 301(e) of the FD&C Act (21 U.S.C. 331(e)) to refuse to permit access to or copying of any record as required by section 704(a). Because your firm failed to respond to the section 704(a)(4) records requests and associated communication attempts, we have no indication of the level of quality assurance for drugs listed as manufactured at your facility.

Also, the FDA contacted your firm on December 18, 2024, to announce an inspection at your manufacturing facility located at 36 Mid Dural Rd., Galston, NSW, Australia. You responded that the registration with the FDA was completed as part of the planning process to explore the potential exporting of products to the United States in the future. You also stated that your facility “had not yet initiated production activities in Australia” and requested to reschedule the inspection. This statement is in contradiction to import records indicating drugs made at this facility were shipped to the United States.

Therefore, FDA placed all drugs manufactured by your firm on Import Alert 66-79 on July 10, 2025. Following your firm’s addition to IA 66-79, you deregistered.

Conclusion

When an owner, operator, or agent delays, denies, limits, or refuses an inspection, the drugs may be deemed adulterated under section 501(j) of the FD&C Act. See FDA’s guidance document Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/circumstances-constitute-delaying-denying-limiting-or-refusing-drug-or-device-inspection.

Until FDA is able to confirm compliance with CGMP and other applicable requirements, we may withhold approval of any new applications or supplements listing your firm as a drug manufacturer. In addition, shipments of articles manufactured at 36 Mid Dural Rd., Galston, NSW, Australia, into the United States that appear to be adulterated or misbranded are subject to being detained or refused admission pursuant to section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3).

After you receive this letter, respond to this office in writing within 15 working days. In response to this letter, you may provide information for our consideration as we continue to assess your activities and practices and/or submit a request to schedule an FDA inspection.

Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3027059496 and ATTN: Vilmary Negrón Rodríguez.

Sincerely,
/S/

Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research