FDA 483 - Bluewave Technologies Inc - May 22, 2026

Bluewave Technologies Inc., a medical device manufacturer in Orange City, FL, was cited for significant deficiencies in its quality management system and unique device identification (UDI) compliance. The inspection revealed a lack of controlled documentation for design, management reviews, internal audits, risk management, and corrective actions, alongside unclosed complaint files. Additionally, the firm's Class 2 BLUEWAVE Disinfection and Deodorization System medical device lacked a UDI on its labels and had no UDI information submitted to the Global Unique Device Identification Database.