FDA 483 - NeuroField, Inc. - May 14, 2025

NeuroField, Inc. in Santa Barbara, CA, was inspected by the FDA, resulting in seven observations related to its manufacturing processes for medical devices. The inspection revealed significant deficiencies in quality system procedures, including inadequate rework procedures, lack of process validation, insufficient supplier management, incomplete design history files, and failures in complaint handling, UDI submission, and internal quality audits. These issues indicate a moderate level of non-compliance with medical device quality system regulations.