FDA 483 - Advance-Esthetic LLC - November 06, 2025

Advance-Esthetic LLC, an initial importer/distributor of medical devices, received a Form FDA 483 with six observations. The inspection revealed significant deficiencies in corrective and preventive action procedures, complaint handling, and regulatory reporting for non-compliant electronic products. Additionally, the firm failed to submit timely annual reports, establish adequate purchasing data requirements, and include required warnings in marketing materials for laser products.