FDA 483 - Freedom Laser Therapy Inc - July 09, 2019

An FDA inspection of Freedom Laser Therapy Inc., a medical device initial importer in Irvine, CA, identified a significant deficiency in its quality system. The firm failed to adequately establish procedures for ensuring purchased products and services conform to specified requirements. This included a lack of completed or approved supplier evaluations and annual re-evaluations for the supplier of iRestore devices.