ScandiDos ABJuly 12, 2018

FDA 483 - ScandiDos AB - July 12, 2018

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Record Details

An FDA inspection of ScandiDos AB, a medical device manufacturer in Uppsala, Sweden, revealed significant deficiencies in their quality management system. The firm was cited for inadequate procedures related to design transfer, control of non-conforming products, and documentation of incoming product acceptance. Additionally, Device History Records were found to be incomplete, lacking critical information.

Company: ScandiDos AB
Inspection Date: July 12, 2018
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Christopher B. May

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ID · ec7a2278-389b-420b-81c0-a462244a9766