FDA 483 - Coronado Aesthetics LLC - August 22, 2025

During an inspection conducted from August 19-22, 2025, the U.S. Food and Drug Administration (FDA) issued a Form FDA-483 to Coronado Aesthetics LLC, a Class II medical device specification developer located in Dallas, TX. The inspection revealed significant deficiencies in the company's quality management system, indicating a lack of adherence to its own established procedures and regulatory requirements. Key observations included inadequate procedures for design validation, specifically concerning insufficient manufacturing and testing runs to support a production scale-up for a Class II device. Furthermore, the firm failed to adequately establish design review procedures, with inconsistent participant records and a lack of documented project team members. Executive management had not reviewed the suitability and effectiveness of the quality system since at least 2021, contrary to their internal requirements for regular management reviews. Lastly, the company failed to perform required quality audits since 2022, neglecting critical internal oversight of its compliance with standards like the US Quality System Regulation (21 CFR Part 820) and ISO 13485. Coronado Aesthetics LLC is responsible for promptly investigating these issues, implementing comprehensive corrective and preventive actions, and ensuring full compliance with its quality system procedures and relevant medical device regulations.