Qiagen Sciences LLCFebruary 21, 2018

FDA 483 - Qiagen Sciences LLC - February 21, 2018

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Record Details

Qiagen Sciences LLC in Germantown, MD, was cited for two significant issues during an FDA inspection. The firm failed to submit Medical Device Reports (MDRs) within the required timeframe for devices that may have caused or contributed to serious injury. Additionally, their complaint files were not adequately maintained, specifically regarding monthly complaint trending and subsequent investigations.

Company: Qiagen Sciences LLC
Inspection Date: February 21, 2018
Product Type: Device
Office: Division of Human and Animal Food Operations - East II
Person: James M. Simpson (investigator)

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ID · 215a9ad8-b17b-4aa2-9efd-222ae52eaa1d