FDA 483 - Creation Technologies - March 11, 2022

An FDA inspection of IEC Electronics in Newark, NY, conducted from March 10-11, 2022, identified one observation. The firm was cited for not adequately conducting and monitoring production processes to ensure device conformity to specifications. Specifically, calibration of the microphone and sound chamber for the Sound Wave Sontro SWH #99000-02 was not properly performed prior to each production run.