# FDA 483 - Matia Robotics US, Inc. - June 05, 2019

Source: https://www.globalkeysolutions.net/records/483/matia-robotics-us-inc/4fb5b084-6319-40b9-b999-86bdfd6ab5f7

> FDA 483 for Matia Robotics US, Inc. on June 05, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Matia Robotics US, Inc.
- Inspection Date: 2019-06-05
- Product Type: device
- Office Name: Denver District Office
- Summary: MATH ROBOTICS US INC, a medical device manufacturer in Salt Lake City, UT, was cited for five observations during an FDA inspection. Key issues included a lack of established procedures for design control, purchasing controls, and acceptance activities. Additionally, the firm failed to properly maintain complaint files and conducted internal quality audits with auditors responsible for the audited processes.

## Related Documents

- [483 - 2023-05-24](https://www.globalkeysolutions.net/records/483/matia-robotics-us-inc/ca6dcd51-f0c4-499b-8396-5aa61219db48)

## Related Officers

- [Consumer Safety Officer/Investigator at FDA](https://www.globalkeysolutions.net/people/marcia-g-evans/2e20a31d-0267-4040-b1a1-c0bec23b964b)

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