# FDA 483 - Theragen, Inc - September 10, 2021

Source: https://www.keypedia.com/records/483/theragen-inc/4274ada4-a40e-48b9-88cb-5f55acb4efbd

> FDA 483 for Theragen, Inc on September 10, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Theragen, Inc
- Inspection Date: 2021-09-10
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Theragen, Inc. in Manassas, VA, a medical device manufacturer, revealed a significant issue regarding document control. The firm was found to be using obsolete labeling specifications for its ActaStim-S Spine Fusion Stimulator device, resulting in finished products being distributed with incorrect labels. This indicates a breakdown in their quality system related to document management and product release.

## Related Documents

- [483 - 2019-05-23](https://www.keypedia.com/records/483/theragen-inc/dcb75d60-6acc-4539-ab40-24537c85d08e)
- [483 - 2020-02-20](https://www.keypedia.com/records/483/theragen-inc/f590c976-2366-47c8-bf64-0101404bb74f)

## Related Officers

- [Jude C. Dike](https://www.keypedia.com/people/jude-c-dike/ea760122-1121-420a-9875-c49de6f3bb0e)

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