FDA WARNING_LETTER - Empower Clinic Services, LLC dba Empower Pharmacy - November 14, 2025

The FDA issued a Warning Letter to Empower Clinic Services, LLC, doing business as Empower Pharmacy, following an inspection conducted from November 3 to November 14, 2025. The investigation revealed that the firm failed to meet the safety exemptions under Section 503A of the Federal Food, Drug, and Cosmetic Act. Specifically, the pharmacy was found to be compounding large volumes of drug products—including Semaglutide and Tirzepatide—that were essentially copies of commercially available medications without sufficient documentation of individual patient needs. Because these conditions were not met, the products are classified as unapproved new drugs and are misbranded. Additionally, the FDA identified significant safety violations related to sterile processing. Key issues included inadequate smoke studies to verify clean airflow and flawed sterility validation tests that lacked reliable documentation and consistent results. These deficiencies create a risk of drug contamination, rendering the products adulterated. To address these concerns, Empower Pharmacy must submit a written response within 15 working days detailing their corrective actions. The FDA also strongly recommends that the company engage a third-party consultant to perform a comprehensive assessment of their manufacturing systems and facility design to ensure compliance with federal safety standards.