483
ZIMMER BIOMET dba Embody, Inc.ZIMMER BIOMET dba Embody, Inc. – FDA 483, Aug 18, 2023
Record Details
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.
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