FDA 483 - Advance-Esthetic LLC - February 07, 2024

Advance-Esthetic LLC, a medical device manufacturer in Fort Lauderdale, FL, received 15 observations during an FDA inspection, with several being repeat findings. The inspection revealed widespread deficiencies in the firm's quality system, including inadequate procedures for laser product controls, nonconforming product, acceptance activities, device master records, complaint handling, and corrective and preventive actions. These issues indicate a systemic failure to establish and implement essential quality system requirements for medical device manufacturing.