# FDA 483 - Murata Vios, Inc. - December 11, 2024

Source: https://www.globalkeysolutions.net/records/483/murata-vios-inc/8df0d036-6cfb-4fda-b08c-ae249380c971

> FDA 483 for Murata Vios, Inc. on December 11, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Murata Vios, Inc.
- Inspection Date: 2024-12-11
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Murata Vios, Inc., a medical device manufacturer in Woodbury, MN, was inspected by the FDA from December 3-11, 2024. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning corrective and preventive actions, design validation, and design verification procedures. These issues indicate a lack of robust controls over product quality and development processes.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/tyler-r-courtney/08ea96c4-cd5a-4793-b7e4-fb2b9ee2b9ef)

Company: https://www.globalkeysolutions.net/companies/murata-vios-inc/226d786c-bd1d-45c5-a515-9c7f3127a8cb

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d