FDA 483 - STAQ Pharma of Ohio, LLC - October 04, 2023

An FDA inspection of STAQ Pharma of Ohio, LLC, an outsourcing facility in Columbus, revealed two significant observations. The firm failed to conduct media fills that accurately simulate its aseptic production operations, using incorrect fill volumes and syringe configurations. Additionally, the environmental monitoring system in aseptic processing areas was found to be deficient, with sample collection points inadequately placed near HEPA filters rather than representative operational areas.