FDA warning letter: AnuMed International, LLC
What the FDA told AnuMed International, LLC in August 2024 about semaglutide — and whether it has been resolved.
“FDA also reviewed your website at the Internet address https://www.anumed-intl.com/ in February and April 2024 and has observed that your website offers “Semaglutide Homeopathic Formula,” “Magnesium 50 mg Body Cream,” “AnuMed™ 25mg Per Pump PROGESTERONE CREAM,” “AnuMed™ 75mg Per Pump PROGESTERONE CREAM,” “AnuMed™ BIO-IDENTICAL BIO-EST 2.5mg PER PUMP,” “AnuMe …”
What an FDA warning letter is
It is a letter. The FDA writes to a company to say which of its practices the agency believes break the law, and asks it to fix them. That is the whole mechanism: a written notice, published so anyone can read it.
It is the FDA’s position, not a court’s finding. The company can reply, and can disagree. The agency states in these letters that failing to address the problems may lead to further action such as seizure or an injunction — which tells you the letter itself is not yet either of those things.
A warning letter does not recall a product, suspend a licence or close a business. It does not mean that medicine already dispensed was unsafe. When the FDA is satisfied the problems are fixed, it publishes a closeout letter.
What it does tell you is that a regulator looked at this company and wanted something changed. The useful question is what — and the quoted passage above answers it more precisely than any summary can.
What the letter says
| Field | What the letter states | Source |
|---|---|---|
| Recipient | AnuMed International, LLC | FDA warning letter |
| Issued | Aug 20, 2024 | FDA warning letter |
| Issuing office | Center for Drug Evaluation and Research (CDER) | FDA warning letter |
| FDA reference | MARCS-CMS 674310 | FDA warning letter |
| Location | Phoenix, AZ, United States | FDA warning letter |
| Subject | Finished Pharmaceutical/Unapproved New Drug/Adulterated/Misbranded | FDA warning letter |
| What it concerns | How the medicine was made | Read from the subject line |
| Medication named | Semaglutide | Letter text |
| Status | Open — no closeout letter published | FDA warning letter list |
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NADAC figures are pharmacy acquisition costs, not retail prices and not what you will pay. This content is educational and is not medical advice.