FDA 483 - Neuro-Fitness LLC - October 18, 2022

Neuro-Fitness LLC, a manufacturer in Fall City, WA, was inspected by the FDA and received a Form 483 with two observations. The inspection revealed significant deficiencies in the firm's complaint handling procedures, including inadequate MDR reportability evaluations, lack of a complaint log, and improper complaint closure. Additionally, the firm failed to adequately implement its internal quality audit procedures, lacking documentation for required audits.