FDA 483 - Bio-Signal Group Corp. - August 30, 2022

Bio-Signal Group Corp. in Acton, MA, a manufacturer of the microEEG device, was cited with four observations during an FDA inspection from August 25-30, 2022. The inspection revealed significant deficiencies in their quality system, including inadequate procedures for corrective and preventive actions, lack of device history records, insufficient environmental controls, and a failure to demonstrate design control compliance. These issues indicate a need for comprehensive improvements across several critical quality system elements.