Neuromonics Inc. – FDA 483, Jan 9, 2020

Neuromonics Inc., a medical device manufacturer in Westminster, CO, received an FDA Form 483 citing nine observations related to its quality system. The inspection revealed systemic deficiencies in maintaining and implementing procedures for critical areas such as MDR reporting, complaint handling, nonconforming product control, process controls, acceptance activities, device history records, supplier management, management review, and quality audits. These issues indicate a significant lack of adherence to established quality system requirements.