FDA 483 - Yukon Medical, LLC - April 06, 2018

An FDA inspection of Yukon Medical, LLC in Durham, NC, revealed significant deficiencies in their medical device design control processes. The firm failed to adequately document design input requirements, establish procedures for design validation, and ensure proper design transfer into production specifications for their AT-ADAPT, 20mm VVAD device. These observations indicate a need for improved quality system procedures in device development.