FDA 483 - Cleartooth Electronics, Inc. - April 19, 2022

Cleartooth Electronics, Inc. in Boulder, CO, a medical device manufacturer, was inspected by the FDA from April 13-19, 2022. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for design change, complaint handling, software validation, document control, and design transfer. These issues indicate a systemic lack of established and maintained quality system procedures.