# FDA 483 - Theragen, Inc - February 20, 2020

Source: https://www.keypedia.com/records/483/theragen-inc/f590c976-2366-47c8-bf64-0101404bb74f

> FDA 483 for Theragen, Inc on February 20, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Theragen, Inc
- Inspection Date: 2020-02-20
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Theragen, Inc, a medical device manufacturer in Manassas, VA, identified one observation related to inadequate documentation of corrective and preventive action (CAPA) activities. Specifically, a CAPA remained open despite a verification effectiveness check being completed. This indicates a deficiency in the firm's quality system regarding CAPA management.

## Related Documents

- [483 - 2019-05-23](https://www.keypedia.com/records/483/theragen-inc/dcb75d60-6acc-4539-ab40-24537c85d08e)
- [483 - 2021-09-10](https://www.keypedia.com/records/483/theragen-inc/4274ada4-a40e-48b9-88cb-5f55acb4efbd)

## Related Officers

- [Wilfred A. Darang](https://www.keypedia.com/people/wilfred-a-darang/f0f1e653-891d-47d6-82e3-5ce40a5d3635)

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