FDA Warning Letter · #715795
PQ Pharmacy, LLC: FDA Warning Letter (October 10, 2025)
PQ Pharmacy, LLC received this warning letter on October 10, 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/pq-pharmacy-llc-715795-10102025
Summary
- Company
- PQ Pharmacy, LLC
- Letter number
- #715795
- Issue date
- October 10, 2025
- Subject
- Compounding Pharmacy/Adulterated Drug Products
What FDA cited
FDA's letter of October 10, 2025 cites PQ Pharmacy, LLC for compounding outside the conditions federal law sets for compounders, under the subject line "Compounding Pharmacy/Adulterated Drug Products". The GLP-1 drugs it names: semaglutide.
During the inspection, the investigator noted that drug products you produced failed to meet the conditions of section 503B of the FDCA necessary for drugs produced by an outsourcing facility to qualify for exemptions from certain provisions of the FDCA. … The FDA investigator also noted CGMP violations at your facility that caused your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA.
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 October 10, 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.
The FDA wrote about how this firm compounds. For what the 503A and 503B rules require: 503A vs 503B compounding pharmacies: who oversees your compounded GLP-1.
FDA’s letter of December 1, 2025 to Apothecary Pharma, LLC also cites its recipient for compounding outside the conditions federal law sets for compounders.
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
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Get started →Other warning letters in our database
- Peak Performance Peptides — August 24, 2026
- Royal Peptides LLC — August 24, 2026
- VivioMD — June 8, 2026
- Bliv — February 20, 2026
- Villas Health — 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