# FDA 483 - Myriad Genetics Laboratories, Inc. - March 28, 2019

Source: https://www.keypedia.com/records/483/myriad-genetics-laboratories-inc/2e01cfec-7928-4811-aad7-cc0900d14235

> FDA 483 for Myriad Genetics Laboratories, Inc. on March 28, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Myriad Genetics Laboratories, Inc.
- Inspection Date: 2019-03-28
- Product Type: device
- Office Name: Denver District Office
- Summary: Myriad Genetics Laboratories, Inc., a medical device manufacturer in Salt Lake City, UT, received an FDA Form 483 with two observations. The inspection revealed that software used as part of the quality system was not validated for its intended use. Additionally, procedures for corrective and preventive actions were found to be inadequately established, lacking appropriate thresholds and proper management of quality problems.

## Related Officers

- [investigator](https://www.keypedia.com/people/christine-i-shaw/480cb61e-f173-432d-b84a-c8b492192302)

Company: https://www.keypedia.com/companies/myriad-genetics-laboratories-inc/98320c70-e9e7-4c1e-855b-5f5c874d701a

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