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

An FDA inspection of Excel Medical Electronics, Inc., a medical device manufacturer in Jupiter, FL, was conducted from March 11-13, 2019. The inspection resulted in an FDA Form 483, detailing several deficiencies in the company's quality system. Key observations included inadequate validation of device software, specifically the Wave Platform, with insufficient documentation for code review and stress testing related to maximum data requests. Training procedures for Software Engineers were also deemed inadequate, lacking documentation on coding standards.

The inspection further noted insufficient documentation of device installation and test results, particularly the absence of checksum verification during copying processes. The design risk analysis (FMEA) for the Wave Platform was incomplete, failing to address critical risks such as intermittent connections or compatibility with untested patient monitor models. Lastly, the company's complaint handling procedures were found to be inadequate, lacking a defined method to ensure timely resolution. These observations indicate that Excel Medical Electronics, Inc. needs to address these issues and implement corrective actions to ensure compliance with federal quality system requirements for medical device manufacturing.