FDA 483 - Health Genesis Corporation - February 18, 2020

Health Genesis Corporation, a dietary supplement manufacturer in Davie, FL, was cited with nine observations during an FDA inspection from January to February 2020. The inspection revealed significant deficiencies in quality control, material handling, equipment calibration, and record-keeping, many of which were recurring issues from previous inspections. These findings indicate a systemic lack of adherence to good manufacturing practices for dietary supplements.