FDA 483 - Advance-Esthetic LLC - March 15, 2022

Advance-Esthetic LLC, an initial importer in Fort Lauderdale, FL, was cited for numerous significant quality system deficiencies during an FDA inspection. The firm failed to establish fundamental procedures for design control, complaint handling, medical device reporting, corrective and preventive actions, acceptance activities, nonconforming product control, and purchasing controls. Additionally, several Class IV laser products lacked required certification labels, hazard warnings, and proper labeling in user manuals and on websites.