Issued to Empower Clinic Services, LLC dba Empower Pharmacy. Serious post-market compliance violation.
Issued
September 18, 2026Product
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
Company
Empower Clinic Services, LLC dba Empower Pharmacy
Review center
CDERStage
Final Decision
Assyro regulatory brief
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FDA issued a warning letter to Empower Clinic Services, LLC dba Empower Pharmacy concerning CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Data integrity and records, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
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Serious post-market compliance violation. Public notice requiring prompt remediation. FDA issued this letter on September 18, 2026.
The firm is expected to respond in writing, normally within 15 working days, describing corrective actions and timelines. FDA verifies remediation — often through reinspection — and issues a closeout letter when violations are corrected. Unresolved warning letters can escalate to import alerts, seizure, or injunction.