FDA 483 - Dominion Aesthetic Technologies Inc. - September 16, 2022

Dominion Aesthetic Technologies Inc. in Winter Park, FL, a medical device specification developer, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately establish and implement procedures for complaint handling, corrective and preventive actions, design control, quality audits, management review, and employee training. Additionally, the company did not submit required electronic product and radiation safety reports for its Eon™ fat reduction medical laser.