FDA WARNING_LETTER - Invigorate Med Spa - August 31, 2025

The FDA issued a Warning Letter to Invigorate Med Spa, located at 8199 McKnight Rd, Pittsburgh, PA, on September 9, 2025, following a review of their website in August 2025. The inspection revealed that the company offers compounded drug products, including semaglutide and tirzepatide, with claims that are false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA). These claims suggest that the products are equivalent to FDA-approved drugs, which they are not, resulting in the products being misbranded.

The regulatory framework cited includes sections 502(a), 502(bb), and 301(a) of the FDCA, which prohibit the introduction of misbranded drugs into interstate commerce. The FDA emphasized that the violations noted are not exhaustive and that Invigorate Med Spa is responsible for ensuring compliance with all federal laws and FDA regulations.

The FDA requires Invigorate Med Spa to take immediate corrective actions, such as ceasing the use of misleading language and addressing all violations. The company must submit a written response within 15 working days to the Office of Compounding Quality and Compliance, detailing the steps taken to rectify the issues and prevent recurrence. Failure to comply may result in legal actions, including seizure and injunction. The letter also advises that misbranded products may be detained or refused entry if the company operates outside the U.S.