DFS Diamon GmbHSeptember 20, 2019

FDA 483 - DFS Diamon GmbH - September 20, 2019

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Record Details

DFS Diamon GmbH, a medical device manufacturer in Riedenburg, Germany, was inspected by the FDA. The inspection revealed significant deficiencies in supplier management, including the use of unapproved suppliers and inadequate procedures for purchased products. Additionally, the firm failed to maintain complete device history records for its medical devices.

Company: DFS Diamon GmbH
Inspection Date: September 20, 2019
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Dedicated Device Cadre
John A. Sciacchitano (investigator)

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ID · 064e1ec7-df48-4725-a249-c15785783ba7