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

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.