FDA 483 - NeuroField, Inc. - October 06, 2021

An FDA inspection of NeuroField, Inc., a medical device manufacturer, was conducted from September 28 to October 6, 2021, revealing multiple deficiencies in its quality management system. The company was cited for failing to adequately establish and implement procedures for receiving and evaluating complaints, with numerous complaint records lacking essential information. Issues were also noted with the corrective and preventive action (CAPA) system, where previous CAPAs had not effectively resolved problems, and some observations mirrored those from a 2018 inspection. Further violations included inadequate purchasing and supplier control, with the firm neglecting to evaluate critical suppliers and lacking clear classification criteria for vendors. The inspection also found a lack of established procedures for the routine calibration, inspection, and maintenance of manufacturing equipment for devices like the X3000 (Plus) and Q21. Additionally, NeuroField, Inc. had not conducted required management review meetings since 2018 or internal quality audits since 2019, as mandated by its own procedures. These observations collectively indicate a systemic failure to adhere to medical device quality system regulations. The company has promised to correct all identified issues.