FDA 483 - NovaSignal Corp. - November 01, 2017

NEURAL ANALYTICS in Los Angeles, CA, a medical device manufacturer, was inspected by the FDA. The inspection revealed significant deficiencies in design control procedures, specifically regarding the establishment of adequate design inputs for their Lucid M1 Transcranial Doppler Ultrasound system. Additionally, the firm's risk analysis for the Lucid M1 system was found to be incomplete, failing to assess critical risks related to calculated values and measurements.