Nalu Medical, Inc.April 28, 2021

FDA 483 - Nalu Medical, Inc. - April 28, 2021

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Record Details

An FDA inspection of Nalu Medical, Inc. in Carlsbad, CA, a manufacturer of the Nalu Neurostimulation System, revealed two significant observations. The firm failed to adequately validate device software, specifically a compiler tool, despite its risk classification. Additionally, procedures for corrective and preventive actions were found to be inadequately established and implemented, with multiple open and delayed CAPA and complaint investigations.

Company: Nalu Medical, Inc.
Inspection Date: April 28, 2021
Product Type: Device
Office: Division of Pharmaceutical Quality Operations IV
Person: Jenny L Mccardell

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ID · d5633733-1b28-400a-9cfc-d50b70399990