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Doseworth

FDA warning letter · #728295

VivioMD: What the FDA Letter Means for What You Pay

Legal name: VivioMD Group LLC

Activesemaglutidetirzepatide
Status

Operating

Concerns

marketing / labeling

Issued

June 2026

Response logged

Not logged

By Marla Whitfield, Pricing Editor

Primary source

Read the original letter on fda.gov →

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/viviomd-group-llc-dba-viviomd-728295-06082026

What FDA cited

Quoted verbatim from the letter dated

Read the full letter →

Violations were identified and documented during a review of VivioMD’s website, https://viviomd.com, FDA Establishment Identifier (FEI) 3044027316, in March 2026. FDA observed that your website offers compounded drug products, including semaglutide and tirzepatide products.

  1. 1

    1. The compounded semaglutide and tirzepatide products displayed on your website identify “VivioMD” on the pictured label, suggesting VivioMD is the compounder of those drugs when in fact it is not.

  2. 2

    Accordingly, these representations cause your compounded drug products to be misbranded under sections 502(a) and 502(bb) of the FD&C Act [21 U.S.C. §§ 352(a) and (bb)].

  3. 3

    1. Identifying the entities that produce the compounded drug products offered on your website;

  4. 4

    2. Providing a representative sample of labeling for such drug products; and

Process

How a warning letter proceeds

  1. 1

    Letter issued

    June 2026

  2. 2

    15-working-day response window

    FDA gives the company 15 working days to respond in writing.

  3. 3

    Close-out, if issued

    FDA may post one once it is satisfied the cited issues have been corrected.

Is VivioMD still operating?

viviomd.com returned a live, fully served storefront on 2026-08-09 — titled "Vivio · Personalized care (Aura system)", trading under the shortened wordmark "vivio", with Women/Men weight-care and longevity paths, an intake assessment and a working sign-in. That is a check of whether the site is up and what it says; it is not a check of anything the letter alleges.

What this means for what you pay

Three letters in this collection say the same single thing — the name on the pictured vial was the storefront's own, and the storefront did not make the drug. What separates this one is that you can now go and read the answer. The page names its fillers outright: "your order may be filled by one of our pharmacy partners: RedRock Pharmacy, Health Warehouse, Precision Medicine, or Triad Rx." It says "VivioMD is not a pharmacy or a manufacturer of any medication." And it tells you the photographs are staged: package images "are for illustration only; actual packaging may vary depending on the compounding pharmacy that prepares your medication." That last line is the whole letter in one sentence, written by the seller. For a buyer the useful move is the one that disclosure makes possible: with a pharmacy's name you can look it up — check the state board, check whether it is a 503A pharmacy or a registered 503B outsourcing facility, check whether it has its own inspection history. Without a name you are trusting a photograph. Nothing here concerns what was in the vials; FDA made no finding about the drug's quality or contents, and has not closed the letter out.

Has VivioMD responded?

As of , FDA’s public tracking for this letter does not show a logged company response. Companies are not required to make a response public, and FDA does not always update this field promptly — this is not evidence VivioMD failed to respond.

Sources

Other letters in this index

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Editorial disclaimer: An FDA warning letter is a public regulatory communication stating the agency's view. It is not a recall, a fine, a criminal charge, an injunction, or a finding that a company has broken the law.