# FDA WARNING_LETTER - orvic  - March 02, 2021

Source: https://www.keypedia.com/records/warning_letter/orvic/64c19c3f-8749-4858-a800-94225c148ead

> FDA WARNING_LETTER for orvic  on March 02, 2021. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: orvic 
- Inspection Date: 2021-03-02
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On February 26, 2021, the FDA issued a Warning Letter to a firm operating the website facemaskandppestore.com, following reviews on August 24, 2020, and January 29, 2021. The firm was found to be offering for sale in the United States a serology test, the "LUNGENE SARS-CoV-V-2 Covid-19 IgG/IgM Rapid Antibody Test Cassette," directly to consumers for at-home use.

This product is deemed a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the "Act"), 21 U.S.C. § 321(h), due to its intended use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. The FDA determined the product is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE). It is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), as the firm failed to notify the agency of its intent to introduce the

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

Company: https://www.keypedia.com/companies/orvic/9bdb915b-798d-4739-8be9-7d87b235dbed

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