FDA 483 - Biomet, Inc. - November 09, 2023

An FDA inspection of Biomet, Inc. in Warsaw, IN, revealed inadequate procedures for process changes, specifically concerning bioburden monitoring for Juggerstich Meniscal Repair and Juggerloc devices. The firm failed to maintain proper bioburden monitoring after a product routing deletion, resulting in the distribution of nonconforming lots. This indicates a serious lapse in quality system controls for medical device manufacturing.