FDA 483 - Amneal Pharmaceuticals, LLC - November 18, 2022

An FDA inspection of Amneal Pharmaceuticals, LLC in Branchburg, New Jersey, a finished product manufacturer, revealed significant deficiencies in quality control and manufacturing processes. Observations included unrecorded deviations from production procedures, insufficient physical separation leading to potential cross-contamination, and a failure to thoroughly review unexplained discrepancies in laboratory testing. These issues indicate a need for improved adherence to established protocols and facility controls.