Ivim Services LLC dba Ivim
FDA issued a warning letter to Ivim Services LLC dba Ivim, a telehealth company based in Columbus, OH, after reviewing its website in December 2025 and finding that it offered compounded semaglutide and tirzepatide products with labeling that falsely identified 'Ivim' as the compounder when it is not. These representations rendered the products misbranded under FDCA sections 502(a) and 502(bb), constituting prohibited acts under section 301(a). FDA required a written response within 15 working days describing corrective steps, and warned that failure to adequately address violations may result in seizure or injunction.
Flagged claims (1)
The compounded semaglutide and tirzepatide products displayed on your website identify "Ivim" on the pictured label, suggesting Ivim is the compounder of those drugs when in fact it is not.
Required actions (3)
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.
Addressing the basis for other website claims that could be construed as false or misleading or demonstrating that such claims have been modified or removed in light of FDCA §§ 502(a) and 502(bb)) [21 U.S.C. §§ 352(a) and (bb)].
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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