FDA Warning Letter · #700962
Empower Pharma — 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-pharma-700962-04022025
Summary
- Company
- Empower Clinic Services, LLC (dba Empower Pharma)
- Letter number
- #700962
- Issue date
- April 2, 2025
- Subject
- Compounding Pharmacy/Adulterated Drug Products
What FDA cited
FDA inspected the 503B outsourcing facility at 5980 West Sam Houston Parkway North, Suite 300, Houston, TX from August 1 to August 28, 2024. FDA states: “the investigators 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. In addition, the investigators noted serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk.”
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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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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