FDA 483 - Examinetics Inc - October 05, 2023

An FDA inspection of Examinetics Inc, a medical device manufacturer in Overland Park, KS, revealed significant quality system deficiencies. The firm failed to ensure design validation for its Class II Salux, Tablet-Controlled Audiometer, specifically regarding Bluetooth connectivity issues identified in pre-deployment testing and post-market complaints. Additionally, the company had not performed required internal quality audits of its quality system for the audiometer.