FDA 483 - NeuroSync, Inc. - February 05, 2025

NeuroSync, Inc. in Holliston, MA, a medical device manufacturer, received a Form FDA 483 with 12 observations during an inspection from January 6 to February 5, 2025. The observations highlight significant deficiencies across multiple quality system areas, including design controls, CAPA procedures, complaint handling, UDI requirements, purchasing controls, risk analysis, and device history records. Several issues, such as design output, CAPA, complaint handling, and purchasing/supplier monitoring, were noted as repeat concerns from previous inspections, indicating systemic problems.