483
Myriad Genetics Laboratories, Inc.Myriad Genetics Laboratories, Inc. – FDA 483, Mar 28, 2019
Record Details
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.
View Company Profile
ID · 2e01cfec-7928-4811-aad7-cc0900d14235
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.