FDA WARNING_LETTER - Bioverse, Inc. dba Bioverse - August 31, 2025

The FDA issued a warning letter to Bioverse on September 9, 2025, following a review of their website in August 2025. The inspection revealed that Bioverse was promoting compounded drug products, specifically semaglutide and tirzepatide, with misleading claims. These claims suggested that the compounded products were equivalent to FDA-approved drugs like Ozempic, Wegovy, Mounjaro, and Zepbound, which they are not. This misrepresentation violates sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA), leading to the products being considered misbranded and unlawfully introduced into interstate commerce under section 301(a) of the FDCA.

The FDA emphasized that compounded drugs are not FDA-approved and that Bioverse"s claims falsely implied equivalence with approved medications. The letter served as a notice of these violations and required Bioverse to take immediate corrective actions. Bioverse must respond within 15 working days, detailing the steps taken to rectify the violations and prevent future occurrences. Failure to comply may result in legal actions, including product seizure and injunctions. Bioverse is also advised to cease using misleading language and ensure all operations comply with federal laws. Correspondence should be directed to the Office of Compounding Quality and Compliance.