FDA 483 - Evergreen Orthopedic Research Lab, LLC dba Xpertiv - April 12, 2019

An FDA inspection of Evergreen Orthopedic Research Lab, LLC dba Xpertiv in Kirkland, WA, a manufacturer of orthopedic accessory devices, revealed significant deficiencies in its quality system. The firm failed to adequately establish procedures for complaint handling and medical device reporting, including a lack of documentation for MDR evaluations and untimely processing of complaints. Additionally, the company used unapproved forms for documenting on-site supplier audits, indicating a breakdown in supplier control procedures.