FDA 483 - Empower Pharmacy - November 03, 2025

The FDA issued a Form 483 to Empower Clinic Services, L.L.C. dba Empower Pharma, an outsourcing facility in Houston, TX, following inspections conducted between November 3 and 14, 2025. The document details significant observations concerning the firm"s compliance with regulations for sterile drug manufacturing. The primary issue (Observation 1) identifies that procedures designed to prevent microbiological contamination of sterile drug products are not adequately established or followed. This includes deficiencies in aseptic process simulations (APS) which did not encompass the full aseptic process, lacked proper risk assessments for interventions, and failed to reflect actual production conditions. Furthermore, the environmental monitoring program was inadequate, particularly regarding dynamic manufacturing operations, and airflow visualization studies were not representative of routine production. A critical repeat observation noted the lack of personnel monitoring after aseptic connections and critical manipulations. Observation 2 highlighted that control procedures were not established to monitor and validate manufacturing processes, with the visual inspection program lacking sufficient scientific justification and controls to identify the origin of product defects. Empower Pharma is required to address these observations with comprehensive corrective and preventive actions to ensure compliance and product quality.