SemaBio – FDA Warning Letter, Aug 31, 2025

The FDA issued a Warning Letter to SemaBio on September 9, 2025, following a review of their website in August 2025. The inspection revealed that SemaBio offers compounded drug products, including semaglutide, with misleading claims. Specifically, the website describes these products as "generic semaglutide," implying equivalence to FDA-approved drugs, which they are not. This constitutes a violation under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], resulting in the misbranding of products. Introducing or delivering these misbranded products into interstate commerce violates section 301(a) of the FDCA [21 U.S.C. § 331(a)].

The FDA requires SemaBio to take immediate corrective actions, including ceasing the use of misleading language. The company must submit a written response within 15 working days to the Office of Compounding Quality and Compliance (OCQC), detailing the steps taken to address the violations and prevent recurrence. Failure to comply may lead to legal actions, such as product seizure or injunctions. SemaBio is also advised that if their products are found to be misbranded, they may be detained or refused entry into the U.S. The letter serves as a formal notice of these issues and provides an opportunity for SemaBio to address them.