# FDA 483 - A3R, Llc - April 10, 2019

Source: https://www.keypedia.com/records/483/a3r-llc/c2334544-200a-45d8-b75c-1531ee1ef420

> FDA 483 for A3R, Llc on April 10, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: A3R, Llc
- Inspection Date: 2019-04-10
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Visual Telecommunication Network, LLC dba Vitel Net in Mc Lean, VA, revealed significant deficiencies in their quality system. The firm failed to establish finished device acceptance procedures, adequately implement corrective and preventive actions, and document software validation activities. These issues indicate a lack of control over critical manufacturing and quality processes for medical devices.

## Related Officers

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

Company: https://www.keypedia.com/companies/a3r-llc/acb99c60-fc9a-434e-9176-b58a63bd98c4

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