# Cerner Enviza LLC – FDA 483, Jun 21, 2017

Source: https://www.keypedia.com/records/483/cerner-enviza-llc/37b6dc31-5298-4329-b275-b15180d2adab

> FDA 483 for Cerner Enviza LLC on June 21, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cerner Enviza LLC
- Inspection Date: 2017-06-21
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Cerner Corporation, a medical device manufacturer in Kansas City, MO, was cited for significant deficiencies in its complaint handling and reporting processes. The inspection revealed failures to submit Medical Device Reports (MDRs) for serious software malfunctions and to report device corrections made to reduce health risks. Additionally, the firm's complaint handling procedures were not consistently implemented, leading to potential patient safety issues going unflagged.

## Related Officers

- [Edward E. Lockwood](https://www.keypedia.com/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)
- [Jose E. Almeida](https://www.keypedia.com/people/jose-e-almeida/1df7930c-d835-4c16-85a0-4c9adbb531a4)
- [Boun M. Xiong](https://www.keypedia.com/people/boun-m-xiong/2c83752d-efe2-4c8e-922f-7ffe135ab017)

Company: https://www.keypedia.com/companies/cerner-enviza-llc/fe45d745-5dc1-4f53-82fc-0eed751c2ecd

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8