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FDA Warning Letter · #700964

Empower Pharmacy — FDA Warning Letter (April 2, 2025)

Legal name: Empower Clinic Services, LLC

Issued April 2, 2025Status: activeCenter for Drug Evaluation and Research (CDER)

In plain English

Compounding pharmacy inspection

FDA inspected Empower Pharmacy’s compounding facility and cited production practices that it said make drugs adulterated under federal law.

What it means for you

This letter is about how drugs were made at the time of FDA’s inspection. If this pharmacy fills your prescription, ask your provider whether the problems have been fixed, and don’t stop a prescribed medicine without talking to your prescriber.

Our Empower Pharmacy review →

Primary Source

View the original FDA letter on fda.gov →

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-700964-04022025

Letter details

Company
Empower Clinic Services, LLC (dba Empower Pharmacy)
Letter number
#700964
Issue date
April 2, 2025
Subject
Compounding Pharmacy/Adulterated Drug Products

What FDA cited

FDA inspected the 503A pharmacy at 7601 N Sam Houston Pkwy W Ste 100, Houston, TX from September 24 to October 4, 2024. FDA states: “the investigators noted serious deficiencies in your practices for producing drug products, which put patients at risk”, and that “it appears that you produced drug products that violate the Federal Food, Drug, and Cosmetic Act (FDCA).”

What FDA warning letters mean

A warning letter is FDA's principal means of telling a company that the agency considers something it's doing — a marketing claim, a manufacturing practice, a labeling choice — to violate the Federal Food, Drug, and Cosmetic Act. Companies typically have 15 working days to respond.

A warning letter is not a recall, a criminal charge, or a finding that the company has broken the law. It is the start of a regulatory conversation. FDA may issue a close-out letter once it is satisfied that the company has corrected the cited issues.

For compounded GLP-1 telehealth providers, the most common citations involve unapproved new drug claims, misbranding, and the use of bulk drug substances not on FDA's approved list under FDCA sections 503A and 503B.

What this letter means if you use compounded GLP-1s

A warning letter is not a recall, and it does not by itself mean a product you already have is unsafe, but it does mean the FDA found problems it expects Empower Pharmacy to fix. Compounded GLP-1s are not FDA-approved, and the rules for selling them changed when the shortages ended; our explainer on where compounded semaglutide stands with the FDA now covers what is still allowed. This letter is also listed on the Empower Pharmacy profile, alongside its other inspections and enforcement history. How Empower Pharmacy handles care and pricing today is in our review of Empower Pharmacy.

How a drug is made is the part of compounding a patient cannot inspect. What PCAB accreditation does and does not tell you and our review of impurities in compounded GLP-1s explain how quality is checked.

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Editorial Disclaimer

FDA warning letters are public regulatory communications and do not, on their own, indicate that a company has done anything illegal. Companies often respond to warning letters with corrective action, and many letters are eventually closed out. The full text of this letter is available on fda.gov via the link above.

Key terms, explained

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