BioDuro, LLC – FDA 483, Feb 23, 2024

BioDuro, LLC, a drug manufacturer in Irvine, CA, was inspected by the FDA and received a Form 483 with eight observations. The inspection revealed significant issues across quality control, production processes, and laboratory controls, including persistent dissolution failures, inadequate equipment design, unvalidated process parameters, and insufficient annual product reviews. These findings indicate a need for substantial improvements in the firm's quality management system to ensure drug product quality and compliance.