Viv Health, Inc. dba VIV RX
FDA issued a warning letter to Viv Health, Inc. dba VIV RX, a telehealth company based in Austin, TX, for misbranding compounded semaglutide and tirzepatide products on its website. The core violation is that the product labels depicted on the website identify 'VIV RX' as the compounder when VIV RX is not actually the compounder, constituting false or misleading labeling under FDCA sections 502(a) and 502(bb). FDA found these products to be misbranded drugs introduced into interstate commerce in violation of section 301(a) of the FDCA. The company was given 15 working days to respond with corrective steps, and FDA warned that failure to comply may result in seizure or injunction.
Flagged claims (1)
VIV RX
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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