FDA 483 - empower clinic services, llc, - November 14, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · ce913383-fac3-4372-ad8f-94b794669a34