# FDA 483 - Dynex Technologies, Inc. - February 18, 2022

Source: https://www.keypedia.com/records/483/dynex-technologies-inc/ee7cb6a3-8ba8-482f-8d1d-a7f53488bc9d

> FDA 483 for Dynex Technologies, Inc. on February 18, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dynex Technologies, Inc.
- Inspection Date: 2022-02-18
- Product Type: device
- Office Name: Office of Regulatory Affairs
- Summary: Dynex Technologies, Inc. in Chantilly, VA, was inspected by the FDA from February 7-18, 2022, and received a Form FDA-483 with three observations. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding corrective and preventive actions, supplier controls, and customer complaint handling processes. These issues indicate a lack of adherence to established procedures and regulatory requirements.

## Related Officers

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

Company: https://www.keypedia.com/companies/dynex-technologies-inc/8525266a-6477-4b5a-a068-e9bb73e08824

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64