483
Nevro CorporationFDA 483 - Nevro Corporation - November 03, 2017
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Record Details
An FDA inspection of Nevro Corporation in Redwood City, CA, revealed multiple significant quality system deficiencies. The firm failed to adequately report medical device adverse events, establish effective corrective and preventive actions, and conduct proper risk analysis. Additionally, complaint investigations were insufficient, and the ethylene oxide sterilization process was not adequately validated.
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ID · b4c81e77-1156-4ba6-9854-95bfecc42b8b