FDA 483 - Prugen Inc. Pharmaceuticals - August 13, 2018

Prugen Inc. Pharmaceuticals in Scottsdale, AZ, was inspected by the FDA from August 9-13, 2018. The inspection identified a significant deficiency in the firm's investigation records for Medical Device Report (MDR) reportable complaints. These records lacked critical information regarding device specifications, usage, relationship to adverse events, investigation details, and corrective actions.