# FDA 483 - Matia Robotics US, Inc. - May 24, 2023

Source: https://www.globalkeysolutions.net/records/483/matia-robotics-us-inc/ca6dcd51-f0c4-499b-8396-5aa61219db48

> FDA 483 for Matia Robotics US, Inc. on May 24, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Matia Robotics US, Inc.
- Inspection Date: 2023-05-24
- Product Type: device
- Office Name: Denver District Office
- Summary: Matia Robotics US, Inc. in Salt Lake City, UT, a medical device manufacturer, was cited for three observations during an FDA inspection. The firm failed to investigate device complaints, lacked documentation for incoming product acceptance, and did not conduct management reviews of the quality system at defined intervals. These issues indicate deficiencies in the firm's quality management and control processes.

## Related Documents

- [483 - 2019-06-05](https://www.globalkeysolutions.net/records/483/matia-robotics-us-inc/4fb5b084-6319-40b9-b999-86bdfd6ab5f7)

## Related Officers

- [James R. Montero](https://www.globalkeysolutions.net/people/james-r-montero/ce2d19fd-25b7-423e-9132-5d6f582380d2)

Company: https://www.globalkeysolutions.net/companies/matia-robotics-us-inc/dc929b91-9863-4c4c-a895-41ce611bb60a

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face