FDA 483 - Coronado Aesthetics LLC - August 22, 2025

Coronado Aesthetics LLC, a class II device specification developer in Dallas, TX, received a Form 483 with four observations. The inspection revealed significant deficiencies in the firm's quality system, including inadequate design validation and review procedures, a lack of management reviews, and a failure to conduct required quality audits. These issues indicate a systemic breakdown in maintaining compliance with regulatory requirements.