FDA EIR - Empower Pharmacy - November 25, 2015

An FDA inspection of Empower Pharmacy, a Houston, TX-based 503A compounding pharmacy producing sterile, injectable drug products, was conducted from November 9 to November 25, 2015. This "for cause" inspection was initiated following a complaint alleging the shipment of drug products not linked to patient-specific prescriptions.

The inspection resulted in an FDA-483 document detailing eleven significant observations concerning manufacturing and quality control practices. Key violations included a failure to investigate sterility failures, incomplete media fill studies, and a lack of validation for critical processes. The firm also failed to consistently perform viable air sampling, surface sampling, and personnel monitoring during production runs. Furthermore, Empower Pharmacy did not adequately substantiate Beyond Use Dates for sterile injectable products extending up to 365 days, nor did it conduct anti-microbial effectiveness testing for preservative-containing products. Additional issues involved insufficient process monitoring, absence of disinfectant effectiveness studies, and a failure to conduct smoke studies to assess air ingress during vial loading.

Management provided a written response to all observations. The FDA's final classification for this inspection was "Official Action Indicated," indicating that regulatory action is warranted.