FDA 483 - Empower Pharmacy - November 12, 2025

Empower Clinic Services, L.L.C. dba Empower Pharma, an outsourcing facility in Houston, was cited for significant deficiencies across its sterile drug manufacturing operations. The inspection revealed critical failures in preventing microbiological contamination, including inadequate aseptic process simulations and environmental monitoring. Additionally, the firm demonstrated a systemic breakdown in its quality control unit, with numerous open nonconformance reports, delayed investigations, and a lack of scientific justification for visual inspection and stability programs.