Pennine HealthcareJuly 5, 2018

FDA 483 - Pennine Healthcare - July 05, 2018

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Record Details

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.

Company: Pennine Healthcare
Inspection Date: July 5, 2018
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Monica C. Burgos Garcia

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ID · f5bb2376-286b-4330-a1f6-a69dae80a47b