Neurometrix, Inc. – FDA 483, May 27, 2026

NeuroMetrix, Inc. in Rockaway, NJ, was inspected regarding its Quell Fibromyalgia device and found to have significant deficiencies across multiple quality system areas. The firm failed to implement adequate Medical Device Reporting procedures, resulting in unreported serious adverse events like burns and neurological issues. Additionally, the inspection revealed failures in complaint investigation documentation, maintenance of risk management records, and proper design verification for the device's mobile application, specifically concerning regulatory labeling requirements.