Julie R. Alcantar
Owner
AnuMed International, LLC
3908 E Broadway Rd, Suite 110
Phoenix , AZ 85040-2995
United States
julie@anumed-intl.comFEI 3010164449Issued Aug 20, 2024Center for Drug Evaluation and Research (CDER)
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3010164449.
Violations9
Issue DateAug 20, 2024
Product TypeDrugs
StatusOpen
Letter Details
Firm
AnuMed International, LLC
Location
Julie R. Alcantar
Owner
AnuMed International, LLC
3908 E Broadway Rd, Suite 110
Phoenix , AZ 85040-2995
United States
julie@anumed-intl.com
FEI Number
3010164449
Country
United States
Issue Date
August 20, 2024
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
AnuMed International, LLC was cited for manufacturing and selling multiple unapproved new drugs without FDA approval, including hormone creams (progesterone, estrogen, DHEA), a semaglutide homeopathic formula, vitamin supplements, and various dietary products, in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act. During an FDA inspection of the Phoenix, Arizona facility in November 2023 and subsequent review of the company's website in February and April 2024, the agency identified that these products were being introduced into interstate commerce without required new drug applications. Several products, including magnesium cream, hormone creams, vitamin formulations, and immune support products, were also found to be adulterated or misbranded.
AnuMed International, LLC FDA Warning Letter, August 20, 2024