FDA WARNING_LETTER - inspire.clinic - August 31, 2025

The FDA issued a Warning Letter to Inspire Clinic, located at 217 W Main Street, Grand Prairie, TX, on September 9, 2025, following a review of their website in August 2025. The inspection revealed that the clinic"s website offers compounded drug products, specifically semaglutide and tirzepatide, with claims that are false or misleading. These claims suggest that the products are equivalent to FDA-approved drugs, which they are not, resulting in misbranding under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA).

The FDA highlighted that compounded drug products are not FDA-approved and that the clinic"s claims imply equivalence to approved products, thus violating section 301(a) of the FDCA. The letter emphasizes that the introduction or delivery of these misbranded products into interstate commerce is prohibited.

Inspire Clinic is required to take immediate action to address these violations, including ceasing the use of misleading language. The clinic must provide a written response to the FDA"s Office of Compounding Quality and Compliance within 15 working days, detailing the steps taken to rectify the issues and prevent future violations. Failure to comply may result in legal action, including seizure and injunction. The clinic is also advised to submit any reasoning or supporting information if they believe their products do not violate the FDCA. Correspondence should be clearly marked as a Response to Warning Letter.