FDA 483 - Azurity Pharmaceuticals, Inc. - February 19, 2025

Azurity Pharmaceuticals, Inc. in Wilmington, MA, was inspected and cited for deficiencies in its complaint handling procedures. The firm failed to ensure adequate investigations for drug product appearance issues, including a lack of retain sample examination by its contract manufacturer, which was approved by Azurity's Quality Assurance. This indicates a significant breakdown in quality control and complaint management.