# FDA 483 - Theragen, Inc - May 23, 2019

Source: https://www.keypedia.com/records/483/theragen-inc/dcb75d60-6acc-4539-ab40-24537c85d08e

> FDA 483 for Theragen, Inc on May 23, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Theragen, Inc
- Inspection Date: 2019-05-23
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Theragen, Inc. in Manassas, VA, a medical device specification developer, was cited for significant deficiencies during an FDA inspection. The firm lacked adequate procedures for medical device reporting, failed to provide sufficient documentation and rationale for design changes, and did not properly control non-conforming products. These observations indicate a need for improved quality system controls for their medical devices, such as the Kneehab XP controller.

## Related Documents

- [483 - 2020-02-20](https://www.keypedia.com/records/483/theragen-inc/f590c976-2366-47c8-bf64-0101404bb74f)
- [483 - 2021-09-10](https://www.keypedia.com/records/483/theragen-inc/4274ada4-a40e-48b9-88cb-5f55acb4efbd)

## Related Officers

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

Company: https://www.keypedia.com/companies/theragen-inc/68912441-b041-4b0f-8fa4-222e1f67b85a

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