# FDA 483 - Bluewave Technologies Inc - May 22, 2026

Source: https://www.keypedia.com/records/483/bluewave-technologies-inc/9acaabca-e84c-44ab-bdd8-e5b661ebbf07

> FDA 483 for Bluewave Technologies Inc on May 22, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bluewave Technologies Inc
- Inspection Date: 2026-05-22
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

## Related Officers

- [Brandon P. Thompson](https://www.keypedia.com/people/brandon-p-thompson/a4e7da4f-2e9c-497c-ae4c-9168a9678b91)

Company: https://www.keypedia.com/companies/bluewave-technologies-inc/fa0c9556-ebdc-4216-bf8e-cdf217df55fe

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6