FDA 483 - Viewray, Inc. - December 16, 2021

An FDA inspection of Viewray, Inc. in Mountain View, CA, revealed significant deficiencies across its quality system, particularly in design controls and post-market surveillance. The firm failed to establish proper design input procedures, validate device designs against user needs, and adequately document corrective and preventive actions. Additionally, Viewray, Inc. did not properly investigate complaints or submit required Medical Device Reports (MDRs) for device malfunctions, indicating a systemic breakdown in ensuring device safety and effectiveness.