FDA 483 - empower clinic services, llc, - November 14, 2025

The FDA inspected Empower Clinic Services, LLC dba Empower Pharmacy in Houston, TX, and issued a Form 483 with six observations. The inspection revealed significant deficiencies in aseptic processing, including microbial contamination, inadequate cleaning and disinfection, poor aseptic technique, disrupted unidirectional airflow, and insufficient smoke studies and media fills. These issues indicate a high risk of product contamination and compromise of sterile drug product quality.