FDA 483 - Nantsound Inc - February 23, 2022

An FDA inspection of Nantsound Inc. in Park Ridge, IL, revealed that the firm's procedures for the rework of nonconforming medical devices were not adequately established. Specifically, the firm failed to complete required deviation forms for reworked HD-100 Hearing Aids and did not document the serial numbers of these reworked devices on their SCARs. This indicates a significant lapse in quality system controls for handling nonconforming products.