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

An FDA inspection of Yukon Medical, LLC, a Durham, NC-based specification developer of Class II medical devices (intravascular administration sets), was conducted from April 2-6, 2018. This Quality System Inspectional Technique (QSIT) Level I assessment, governed by regulatory frameworks for medical device manufacturers, focused on design controls, corrective and preventive actions, complaint handling, and purchasing controls.

The inspection revealed significant deficiencies, resulting in a Form FDA-483 with three main observations. First, design input requirements for the AT-ADAPT 20mm VVAD device were not adequately documented, with inappropriate reliance on older documentation for a different product (21 CFR 820.30(c)). Second, the company lacked established procedures and records for design validation activities, failing to ensure the device conformed to user needs (21 CFR 820.30(g)). Third, procedures for design transfer were insufficient, as the device master record for the AT-ADAPT 20mm VVAD did not fully detail production specifications, components, methods, or quality assurance (21 CFR 820.30(h)).

Beyond formal observations, the FDA discussed the importance of reporting foreign adverse events, adequately documenting design output, evaluating employee comprehension during training, and improving contract manufacturer agreements. Management acknowledged the findings, committing to implement necessary Quality System corrections. They also submitted previously unreported foreign adverse events during the inspection. The FDA emphasized that these observations are significant and require prompt attention to avoid potential regulatory sanctions.