FDA Warning Letter · #716152
Darmerica, LLC: FDA Warning Letter (December 8, 2025)
Darmerica, LLC received this warning letter on December 8, 2025, 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/darmerica-llc-716152-12082025
Summary
- Company
- Darmerica, LLC
- Letter number
- #716152
- Issue date
- December 8, 2025
- Subject
- CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded
What FDA cited
FDA's letter of December 8, 2025 cites Darmerica, LLC for manufacturing-practice (CGMP) violations, under the subject line "CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded". The GLP-1 drugs it names: retatrutide and cagrilintide.
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your APIs are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B). Your introduction or delivery for introduction into interstate commerce of adulterated drugs is a violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
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 December 8, 2025. 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 January 16, 2026 to Boothwyn Pharmacy, LLC also cites its recipient for manufacturing-practice (CGMP) violations.
From the letter
Read full letter on FDA.gov →Word for word, from the letter of December 8, 2025
The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Darmerica, LLC, FEI 3012389174, at 4380 Oakes Road, Suite 800, Davie, from March 3 through 19, 2025.
This warning letter summarizes significant violations, including deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your APIs are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B). Your introduction or delivery for introduction into interstate commerce of adulterated drugs is a violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
In addition, Darmerica has distributed drugs that are misbranded within the meaning of section 502(a) of the FD&C Act, 21 U.S.C. 352(a), due to false or misleading labeling, and section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), due to labeling without adequate directions for use. Darmerica also distributed drugs that are misbranded within the meaning of section 502(o) because they were not properly listed in accordance with section 510(j) of the FD&C Act, 21 U.S.C. 360(j), and 21 CFR Part 207. Your receipt in interstate commerce of misbranded drugs, and your introduction or delivery for introduction into interstate commerce of misbranded drugs, violate sections 301(c) and 301(a) of the FD&C Act, 21 U.S.C. 331(c) and 331(a), respectively.
In addition, failure to provide listing information for a drug in accordance with 510(j) of the FD&C Act is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p).
We reviewed your April 7, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.
During our inspection, our investigators observed specific deviations including, but not limited to, the following.
Failure of your quality unit to exercise its responsibility to ensure that APIs manufactured at your facility are in compliance with CGMP.
Quoted word for word from the U.S. Food and Drug Administration. We assert nothing beyond what the agency published, and the full letter is at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025
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.
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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
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- 503B outsourcing facility · Pharmacy and drug forms
- PCAB accreditation · Pharmacy and drug forms
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