ENDOMAGNETICS LTDMay 17, 2018

FDA 483 - ENDOMAGNETICS LTD - May 17, 2018

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Record Details

An FDA inspection of ENDOMAGNETICS LTD, a medical device manufacturer in Cambridge, United Kingdom, identified deficiencies in their quality system. The firm failed to adequately document verification actions for corrective and preventive actions (CAPA). This indicates a lack of robust control over the effectiveness of their corrective measures.

Company: ENDOMAGNETICS LTD
Inspection Date: May 17, 2018
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Marissa Steinhagen (investigator)

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ID · b701020f-cb9c-4126-abc1-4f9236a61cf1