FDA 483 - Aesthetics Biomedical, Inc. - January 21, 2020

Aesthetics Biomedical, Inc., an initial importer and distributor of the Class II Vivace Fractional Microneedle RF System, was inspected by the FDA. The inspection revealed significant deficiencies in the firm's quality system, specifically the lack of established written procedures for critical activities such as Medical Device Reporting, servicing, rework of nonconforming products, and overall document control. These findings indicate a severe lack of foundational quality system controls.