# FDA 483 - Medical Decision Network, LLC - May 25, 2021

Source: https://www.globalkeysolutions.net/records/483/medical-decision-network-llc/b8d85043-48d1-4867-afd1-53bd6011327c

> FDA 483 for Medical Decision Network, LLC on May 25, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medical Decision Network, LLC
- Inspection Date: 2021-05-25
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Medical Decision Network, LLC in Charlottesville, VA, identified a significant issue with document control procedures. The firm failed to adequately document process deviations, specifically lacking completion dates, communication, retraining, and monitoring requirements for all seven deviations reviewed since February 2019. This indicates a moderate severity issue related to quality system compliance.

## Related Officers

- [Tiki Dixon](https://www.globalkeysolutions.net/people/tiki-dixon/b3160a2c-ef16-4fa2-b9b9-4c3a0ed17c5b)

Company: https://www.globalkeysolutions.net/companies/medical-decision-network-llc/b702f73f-a605-4fe0-925c-a2810888ffde

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e