FDA 483 - DEPUY (IRELAND) - December 09, 2016

An FDA inspection of DePuy (Ireland), a medical device manufacturer in Cork, identified significant deficiencies in their quality system. Observations included inadequate device history records for Pinnacle Acetabular Cups, ineffective corrective and preventive action procedures, and insufficient validation of critical manufacturing processes. These issues indicate a lack of control over manufacturing operations and quality management.