FDA Warning Letter · #700964
Empower Pharmacy — FDA Warning Letter (April 2, 2025)
Legal name: Empower Clinic Services, LLC
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
Summary
- 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.
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Mainstream telehealth GLP-1 access
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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
New to GLP-1s? Tap any term for a quick, plain-English definition.
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