FDA 483 - GOOD DOCTORS CO., LTD. - May 23, 2019

An FDA inspection of GOOD DOCTORS CO., LTD. in Incheon, Korea, revealed significant deficiencies in their quality system for manufacturing the Dr's Light G dental composite curing light. The firm lacked adequate procedures for design change, validation, and verification, as well as for handling complaints and Medical Device Reporting. Additionally, equipment calibration procedures were not properly followed.