FDA 483 - Kimball Electronics - Indianapolis - February 24, 2022

An FDA inspection of Kimball Electronics - Indianapolis revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for design verification, corrective and preventive actions, and in-process product control. These issues could lead to critical device malfunctions, including inaccurate drug delivery or device failure, posing a risk of injury or death to users.