Prugen Inc. PharmaceuticalsAugust 13, 2018

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

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Record Details

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.

Company: Prugen Inc. Pharmaceuticals
Inspection Date: August 13, 2018
Product Type: Device
Office: Denver District Office
Person: Maksim A. Levenchuk (investigator)

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ID · 085fbe7f-b17a-47b8-8871-47c19dc03a04