Threshold NeuroDiagnostics Llc – FDA 483, Sep 14, 2021

Threshold Neurodiagnostics Llc in Minoa, NY, a medical device specification developer and labeler, was inspected by the FDA and received a Form 483. The inspection revealed a pervasive lack of established procedures and documentation across nearly all aspects of its quality system, including design controls, device master records, purchasing, quality audits, equipment calibration, corrective and preventive actions, complaint handling, and nonconforming product control. These findings indicate significant deficiencies in the firm's adherence to medical device quality system regulations.