FDA 483 - Polarean, Inc. - September 07, 2021

Polarean Inc. in Durham, NC, a combo drug/device manufacturer, was inspected by the FDA from August 30 to September 7, 2021. The inspection revealed a significant issue with design validation, specifically that the hyperpolarizer device was not validated using production-equivalent units. Furthermore, changes made to the device and a change in contract manufacturer were not properly documented or re-evaluated, indicating potential deficiencies in quality system controls for device design and manufacturing.