FDA 483 - Neuromechanical Innovations, LLC - December 13, 2023

Neuromechanical Innovations, LLC, a medical device manufacturer in Chandler, AZ, was cited for significant deficiencies during an FDA inspection. The firm failed to include unique device identifiers (UDI) on medical device labels for its Impulse/Impulse iQ adjustment tools. Additionally, the company had not conducted required management reviews or quality audits for the past two years, indicating a lapse in quality system oversight.