FDA 483 - GLPGCP Development (Asia) Pte. Ltd. - June 22, 2017

An FDA inspection of GPC Medical Ltd. in New Delhi, India, revealed significant deficiencies in their quality system for device manufacturing. The firm was cited for inadequate procedures concerning labeling activities, process validation, and the acceptance and control of both in-process and finished devices. These observations highlight a need for comprehensive improvements in their operational controls.