FDA 483 - Vivalnk, Inc. - December 10, 2021

Vivalnk, Inc. in Campbell, CA, a manufacturer of medical devices, was cited with five observations during an FDA inspection from December 6-10, 2021. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for design changes, complaint handling, corrective and preventive actions, document control, and employee training. These issues indicate a systemic lack of adherence to established quality management practices for medical device manufacturing.