FDA 483 - Widex Hearing Aid - October 20, 2025

An FDA inspection of WS Audiology USA Inc. in Hauppauge, NY, identified a significant issue with the firm's complaint handling procedures. The company's documented procedure for receiving, reviewing, and evaluating complaints was found to be inadequate, specifically lacking detailed instructions for investigation and documentation of internal records. This indicates a deficiency in the firm's quality system regarding complaint management.