FDA 483 - Otodynamics Limited - July 27, 2022

Otodynamics Limited, a manufacturer in Hatfield, Hertfordshire, was inspected by the FDA from July 25-27, 2022. The inspection revealed that the firm's procedures for receiving, reviewing, and evaluating complaints were not adequately established. Specifically, complaints were not consistently processed in a timely manner, with several files exhibiting extended open periods.