Invigorate Med Spa
FDA issued a warning letter to Invigorate Med Spa (Pittsburgh, PA) in September 2025 after reviewing their website and finding that compounded semaglutide and tirzepatide products were marketed using the brand names of FDA-approved drugs (Wegovy and Mounjaro), falsely implying equivalence with those approved products. These claims were found to misbrand the compounded products under FDCA sections 502(a) and 502(bb), constituting prohibited introduction of misbranded drugs into interstate commerce under section 301(a). The FDA demanded immediate cessation of the misleading language and required a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.
Flagged claims (2)
Semaglutide (Wegovy)
Tirzepatide/B12 (Mounjaro)
Required actions (3)
You should take immediate action to address any violations (including, for example, ceasing and desisting from using the language cited above that misbrands the product).
Within fifteen (15) working days of receipt of this letter, please provide a written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)'s Office of Compliance describing the specific steps you have taken to address any violations.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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