# FDA 483 - Biowave Corporation - June 21, 2023

Source: https://www.globalkeysolutions.net/records/483/biowave-corporation/bb10912d-450f-4e43-9d03-0096a5feb820

> FDA 483 for Biowave Corporation on June 21, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biowave Corporation
- Inspection Date: 2023-06-21
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Biowave Corporation, a medical device manufacturer in Norwalk, CT, received a Form FDA 483 with four observations during an inspection. The firm was cited for significant deficiencies in its quality system, including inadequate procedures for complaint handling and supplier qualification. Additionally, the inspection revealed a complete lack of internal quality audits and management reviews, indicating systemic failures in maintaining an effective quality system.

## Related Officers

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

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

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7