# FDA WARNING_LETTER - Vivera Pharmaceuticals, Inc. - August 10, 2021

Source: https://www.keypedia.com/records/warning_letter/vivera-pharmaceuticals-inc/ee9b9ab8-7a8d-4b7b-987c-b0f870e0d47f

> FDA WARNING_LETTER for Vivera Pharmaceuticals, Inc. on August 10, 2021. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Vivera Pharmaceuticals, Inc.
- Inspection Date: 2021-08-10
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On July 26, 2021, the FDA issued a Warning Letter to Vivera Pharmaceuticals regarding the sale of "COVxRDA Saliva Antigen Test" and "COVx-RDA Nasal Antigen Test" (COVxRDA Antigen Test Kits) on their websites, https://viveracovid19.com/covx-rda/ and https://viverapharmaceuticals.com/products/. The FDA reviewed these websites on January 13, March 3, and April 1, 2021.

The FDA determined that the COVxRDA Antigen Test Kits are intended for COVID-19 mitigation, prevention, treatment, diagnosis, or cure, classifying them as devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h).

The products were offered for sale without FDA marketing approval, clearance, or authorization. Consequently, the COVxRDA Antigen Test Kits are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), due to the lack of approved premarket approval (PMA) or investigational device exemption (IDE) applications. They are also misbranded under section 502(o) of the

## Related Documents

- [WARNING_LETTER - 2021-04-01](https://www.keypedia.com/records/warning_letter/vivera-pharmaceuticals-inc/f2771172-d359-4b5e-95f0-ebb29db92a64)

## Related Officers

- [Director](https://www.keypedia.com/people/timothy-t-stenzel/c53bdcbc-5f38-4c82-b8fc-181624201c10)

Company: https://www.keypedia.com/companies/vivera-pharmaceuticals-inc/dd2992f1-d033-45ff-9bb1-13b0d6498815

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7