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

Source: https://www.keypedia.com/records/483/excel-medical-electronics-llc/100ae121-5ea6-4601-8c61-e50fe2a19625

> FDA 483 for Excel Medical Electronics LLC on March 13, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Excel Medical Electronics LLC
- Inspection Date: 2019-03-13
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

## Related Documents

- [483 - 2019-03-13](https://www.keypedia.com/records/483/excel-medical-electronics-llc/9539abb3-130d-4fc3-928c-df1bc0f482c8)

## Related Officers

- [Principal ](https://www.keypedia.com/people/richard-k-vogel/3ddd8bff-24fd-40ee-b0a7-fb5333a520f5)

Company: https://www.keypedia.com/companies/excel-medical-electronics-llc/ba31f7fc-d704-4031-b0a2-b71e6d70cc46

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6