FDA 483 - Excel Medical Electronics LLC - March 13, 2019

Excel Medical Electronics, Inc. in Jupiter, FL, a medical device manufacturer, received a Form FDA 483 with five observations during an inspection from March 11-13, 2019. The observations primarily concern inadequate software validation, insufficient training procedures for software engineers, improper documentation of device installation, undocumented design risk analysis results, and deficiencies in complaint handling procedures. These issues indicate a need for improvement in the firm's quality system for medical device manufacturing.