FDA 483 - Neuronetrix Solutions, LLC - November 07, 2022

Neuronetrix Solutions, LLC, a medical device manufacturer in Louisville, KY, was cited for multiple quality system deficiencies during an FDA inspection. Observations included inadequate complaint handling, insufficient documentation of corrective and preventive actions, and failures in design control and product nonconformance management. The firm also lacked proper documentation for device history records, corrections/removals, and personnel training, and was found using obsolete procedures.