FDA 483 - Empower Pharmacy - March 06, 2020

Empower Clinic Services, LLC, an outsourcing facility in Houston, TX, was cited for significant deficiencies during an FDA inspection. Observations included inadequate environmental monitoring in aseptic processing, failure to establish validated hold-times for sterile drug products, and a lack of adherence to quality control unit procedures. The firm was also found to be compounding drugs that are essentially copies of approved drugs, failing to include required adverse event reporting information on container labels, and not submitting adverse event reports to the FDA.