Warning Letter — Empower Clinic Services, LLC dba Empower Pharmacy
The FDA issued a Warning Letter to Empower Clinic Services, LLC (dba Empower Pharmacy) following an inspection by the Center for Drug Evaluation and Research (CDER).
This affects Empower Clinic Services, LLC, its compounding pharmacy operations, and regulatory/quality personnel responsible for maintaining compliance with drug manufacturing and compounding standards.
The issuance of a Warning Letter by CDER indicates that the agency identified significant deviations from regulatory requirements that were not sufficiently addressed by the firm's initial responses. This suggests potential risks in the facility's quality control or production processes that could lead to further enforcement actions if not remediated.
Review current compounding practices against established CGMP and state pharmacy standards. Ensure all corrective actions following an inspection are documented, validated, and sustained to prevent escalation to formal warning letters.
FDA Warning Letter issued to: Empower Clinic Services, LLC dba Empower Pharmacy. 09/18/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026
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