# Biowave Corporation – FDA 483, May 26, 2026

Source: https://www.keypedia.com/records/483/biowave-corporation/36e2b786-ab1c-490e-bef2-cd635d86296a

> FDA 483 for Biowave Corporation on May 26, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biowave Corporation
- Inspection Date: 2026-05-26
- Product Type: device
- Office Name: Center for Devices and Radiological Health
- Summary: An FDA inspection of Biowave Corporation in Westport, CT, revealed significant deficiencies across its manufacturing operations. The firm failed to provide adequate resources for its quality management system, exhibited inadequate incoming inspection procedures for its Biowave Home medical device, and did not timely submit a required Medical Device Report (MDR). These issues indicate a systemic lack of control over critical quality processes and regulatory compliance.

## Related Documents

- [483 - 2023-06-21](https://www.keypedia.com/records/483/biowave-corporation/bb10912d-450f-4e43-9d03-0096a5feb820) — date: June 21, 2023

## Related Officers

- [Katarzyna Plona](https://www.keypedia.com/people/katarzyna-plona/ea20d6c6-5d2d-41a0-a755-0647fb9f3250)

Company: https://www.keypedia.com/companies/biowave-corporation/ae8cd2b2-5da4-4aef-91a8-43c9dadd067a

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7