# FDA 483 - Murata Vios Inc. - April 25, 2024

Source: https://www.keypedia.com/records/483/murata-vios-inc/02c51e48-36a5-4e61-932b-50b7c1708b36

> FDA 483 for Murata Vios Inc. on April 25, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Murata Vios Inc.
- Inspection Date: 2024-04-25
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Murata Vios Inc. in Duluth, GA, a medical device manufacturer, was cited with two observations during an FDA inspection from April 23-25, 2024. The inspection revealed deficiencies in document control procedures, including issues with nonconformance reporting and returned material authorization processes. Additionally, the firm failed to adequately establish procedures for device history records for its Vios device.

## Related Officers

- [Dawn M. Braswell](https://www.keypedia.com/people/dawn-m-braswell/6a66fdbb-fff8-4b4b-9f06-320464957b87)

Company: https://www.keypedia.com/companies/murata-vios-inc/833fbf1c-4652-424a-ace7-0f9034988d0f

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7