FDA 483 - King Systems Corp. dba Ambu, Inc. - April 15, 2021

An FDA inspection of King Systems Corp. dba Ambu, Inc. in Noblesville, Indiana, from April 13-15, 2021, revealed a significant quality system deficiency. The firm failed to adequately document the results of its design risk analysis, specifically regarding mitigations for reversed images on the King Vision Video Laryngoscope Adapter. This issue highlights a lack of proper documentation and design input identification, which previously led to a device recall.