FDA 483 - ZIMMER BIOMET dba Embody, Inc. - August 18, 2023

An FDA inspection of ZIMMER BIOMET dba Embody, Inc. in Norfolk, VA, revealed significant deficiencies in their quality system. The firm failed to adequately establish and implement procedures for finished device acceptance, including incoming inspection, and also had inadequate procedures for receiving, reviewing, and evaluating complaints, leading to insufficient investigations of device malfunctions.