Warning letterPosted September 22, 2026
FDA warning letter to Empower Clinic Services, LLC dba Empower Pharmacy
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
FDA posted a warning letter to Empower Clinic Services, LLC dba Empower Pharmacy on September 22, 2026; the letter is dated September 18, 2026. Subject: CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug. Issuing office: Center for Drug Evaluation and Research (CDER).
On the record
- Company
- Empower Clinic Services, LLC dba Empower Pharmacy
- Subject
- CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
- Issuing office
- Center for Drug Evaluation and Research (CDER)
- Letter dated
- 2026-09-18
- Posted by FDA
- 2026-09-22
- Source
- FDA warning letters ↗
CFR cited
The record cites 7 sections of 21 CFR Parts 200, 201, 210 and 211.
The full record
An account shows the violations FDA described and each CFR section it cited.
What a warning letter is
A warning letter is FDA's notice to a company that it found significant violations of federal requirements. FDA asks for a written response, normally within 15 working days. The letter is advisory: it states the agency's position and is not a final agency action.
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From FDA warning letters. The record may have changed since it was read.
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