# FDA 483 - Pyrexar Medical, Inc. - May 18, 2022

Source: https://www.keypedia.com/records/483/pyrexar-medical-inc/dd79640f-f64b-427c-a8de-70ecf1a579a8

> FDA 483 for Pyrexar Medical, Inc. on May 18, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pyrexar Medical, Inc.
- Inspection Date: 2022-05-18
- Product Type: device
- Office Name: Denver District Office
- Summary: An FDA inspection of Pyrexar Medical, Inc. in West Valley City, UT, from May 9-18, 2022, revealed a significant quality system deficiency regarding complaint handling. The firm failed to properly investigate customer complaints or document justifications for not investigating them, as required by their procedures. This indicates a breakdown in their complaint management process for medical devices.

## Related Officers

- [Rebecca L. Stephany](https://www.keypedia.com/people/rebecca-l-stephany/33f38e32-c0a6-4292-a515-ab3f6ca6503a)
- [James R. Montero](https://www.keypedia.com/people/james-r-montero/ce2d19fd-25b7-423e-9132-5d6f582380d2)

Company: https://www.keypedia.com/companies/pyrexar-medical-inc/28a81a86-e004-4cab-9d6c-36a492f09349

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