AnuMed International, LLC – FDA Warning Letter, Nov 7, 2023
On August 20, 2024, the FDA issued a Warning Letter to AnuMed International, LLC, following an inspection from November 1-7, 2023, and a review of their website in February and April 2024. The letter identifies multiple violations related to unapproved new drugs, misbranded drugs, and current Good Manufacturing Practice (CGMP) deficiencies.
The FDA determined that numerous products, including "Semaglutide Homeopathic Formula," various "PROGESTERONE CREAM," "BIO-EST," and "ESTRIOL CREAM" products, "DHEA CREAM," "50,000 IU Vitamin D3+K2 CREAM," "Travel Safe Drops," "Vitamin C Booster," "Immune Booster," "Vegan Vitamin D3 K2 Capsules," "B-12 Drops," "Zinc Drops," and "Turmeric Curcumin Drops," are unapproved new drugs. These products are marketed with drug claims (e.g., weight loss, hormone balance, disease treatment) but lack FDA approval, violating sections 505(a) and 301(d) of the FD&C Act.
Several products, including "Magnesium 50 mg Body Cream" and various hormone creams, are also deemed misbranded under section 502(a) for misleadingly suggesting FDA approval or endorsement (e.g., "FDA * APPROVED * FACILITY"). Additionally
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