FDA 483 - Biomet, Inc. - January 30, 2020

An FDA inspection of Zimmer Biomet, Inc. in Warsaw, IN, revealed significant deficiencies in their quality system, particularly concerning process validation, corrective and preventive actions (CAPA), and environmental controls for medical devices. The firm failed to adequately validate sterilization and cleaning processes, experienced delays in addressing a Class II recall related to elevated endotoxins, and exhibited inadequate design control and nonconforming product procedures. Several observations were repeats from a previous 2018 inspection, indicating persistent issues.