FDA Warning Letter · #674310
AnuMed International, LLC: FDA Warning Letter (August 20, 2024)
AnuMed International, LLC received this warning letter on August 20, 2024, from FDA’s Center for Drug Evaluation and Research (CDER). What it cites, and FDA’s own words where we matched them against the letter, are summarized below.
Primary Source
View the original FDA letter on fda.gov →
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/anumed-international-llc-674310-08202024
Summary
- Company
- AnuMed International, LLC
- Letter number
- #674310
- Issue date
- August 20, 2024
- Subject
- Finished Pharmaceutical/Unapproved New Drug/Adulterated/Misbranded
What FDA cited
FDA's letter of August 20, 2024 cites AnuMed International, LLC for selling products FDA calls unapproved new drugs, under the subject line "Finished Pharmaceutical/Unapproved New Drug/Adulterated/Misbranded". The GLP-1 drugs it names: semaglutide.
As described below, your above-mentioned products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). … In addition, because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).
How this letter sits against the other 159
Our reading, from the 160 letters on this register — not part of the FDA’s document.
No other letter on this register carries the date August 20, 2024. The agency acted against this company on its own that day, which is uncommon here — most of the letters we hold arrived in sweeps.
A warning letter is the agency putting a company on notice, not a court finding and not a ban. What it is worth to you is in what it alleges, so read the original on fda.gov rather than the fact that one exists.
For how this letter fits the wider run of GLP-1 warning letters: What the FDA's GLP-1 warning letters say about this market.
FDA’s letter of September 12, 2024 to Nomidabiz also cites its recipient for selling products FDA calls unapproved new drugs.
What FDA warning letters mean
It is the agency writing to a company to say it believes something that company is doing breaks the Federal Food, Drug, and Cosmetic Act — usually a claim on a website, a labeling choice, or how a drug is being made. The company has about fifteen working days to write back.
Read carefully what it is not. It is not a recall, not a criminal charge, and not a court deciding anyone broke the law. It is the regulator opening a file. Companies frequently answer a letter, fix what was cited, and carry on trading, and when FDA accepts that it can issue a close-out letter. We do not track close-outs, so the presence of a letter on this page tells you what FDA said on one date — not where the matter stands today. Ask the company; they will usually tell you, and how they answer is informative in itself.
Across this market the same three citations recur: claiming a compounded product is equivalent to an approved one, labeling that misleads, and compounding from bulk substances FDA has not cleared under sections 503A and 503B. If you are reading a letter here, it is probably one of those.
Where to get GLP-1 online, safely: sellers our editors have checked
These are telehealth sellers our editors have checked. For each one we hold a price, the form the drug comes in, and the states it reaches.
No insurance needed · vetted by our editors
Some of the links on this page earn us money. If you sign up with a provider after following one, that provider may pay GLP Watchdog a commission. Learn more
Sesame Care
Oral orforglipron alongside the injectables
From $149/mo + care fee
Get started →Oak
A choice of compounded injections, oral semaglutide and brand-name GLP-1s from one cash-pay checkout
From $100/mo
Get started →bmiMD
Starting below a standard dose, with microdose tiers
From $129/mo, prepaid
Get started →Other warning letters in our database
- Strut — February 20, 2026
- FitRx — February 20, 2026
- Thrive Health Solutions — February 9, 2026
- Elevated — September 9, 2025
- DirectMeds — September 9, 2025
Editorial Disclaimer
This is a public communication from a regulator, and by itself it settles nothing about whether the company broke any law. Corrective action is a common response, and a fair number of letters end in a close-out. Read the whole thing on fda.gov through the link above rather than taking our excerpt as the full picture.
Glossary
The words sellers use, defined. Tap any term.
- Compounded GLP-1 · Pharmacy and drug forms
- 503A pharmacy · Pharmacy and drug forms
- 503B outsourcing facility · Pharmacy and drug forms
- PCAB accreditation · Pharmacy and drug forms
- FDA Warning Letter · Insurance and regulatory
- Off-label use · Insurance and regulatory
- FDA Drug Shortage List · Insurance and regulatory