FDA 483 - Pennine Healthcare - July 05, 2018

An FDA inspection of Pennine Healthcare in Cardiff, UK, from July 2-5, 2018, identified significant deficiencies in the firm's corrective and preventive action (CAPA) procedures. The company's CAPA system failed to adequately evaluate non-conformities, document activities and results, and incorporate all quality data sources. This indicates a moderate severity issue regarding quality system controls for medical device manufacturing.