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

The FDA issued a warning letter on September 9, 2025, to iVisitDoc, located at 7345 Woodland Drive, Suite I, Indianapolis, IN, following a review of their website in August 2025. The FDA identified that iVisitDoc"s website offers compounded semaglutide drug products with claims that are false or misleading, violating sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA). These claims suggest that the compounded products are equivalent to FDA-approved drugs like Wegovy and Ozempic, which they are not, leading to their classification as misbranded drugs.

The regulatory framework cited includes sections 502(a), 502(bb), and 301(a) of the FDCA, which address false or misleading labeling and the prohibition of introducing misbranded products into interstate commerce. The FDA requires iVisitDoc to take immediate corrective actions, such as ceasing the use of misleading language and ensuring compliance with federal law.

iVisitDoc must respond within 15 working days, detailing the steps taken to rectify the violations and prevent recurrence. Failure to comply may result in legal actions, including seizure or injunction. The company is also advised to provide a rationale if they believe their products are not in violation, along with supporting information. Correspondence should be directed to the Office of Compounding Quality and Compliance within the FDA"s Center for Drug Evaluation and Research.