Warning letterPosted October 21, 2025
FDA warning letter to Melcare Biomedical Pty Ltd
Nonprescription/OTC
FDA posted a warning letter to Melcare Biomedical Pty Ltd on October 21, 2025; the letter is dated October 9, 2025. Subject: Nonprescription/OTC. Issuing office: Center for Drug Evaluation and Research (CDER).
On the record
- Company
- Melcare Biomedical Pty Ltd
- Subject
- Nonprescription/OTC
- Issuing office
- Center for Drug Evaluation and Research (CDER)
- Letter dated
- 2025-10-09
- Posted by FDA
- 2025-10-21
- Source
- FDA warning letters ↗
CFR cited
The record cites 2 sections of 21 CFR Part 201.
The full record
An account shows the violations FDA described and each CFR section it cited.
What a warning letter is
A warning letter is FDA's notice to a company that it found significant violations of federal requirements. FDA asks for a written response, normally within 15 working days. The letter is advisory: it states the agency's position and is not a final agency action.
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