# FDA WARNING_LETTER - Fair Price Labs, Inc. - July 21, 2020

Source: https://www.keypedia.com/records/warning_letter/fair-price-labs-inc/21637082-3622-4f0a-b826-61175e767c6d

> FDA WARNING_LETTER for Fair Price Labs, Inc. on July 21, 2020. Product: Devices. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Fair Price Labs, Inc.
- Inspection Date: 2020-07-21
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On July 24, 2020, the FDA issued a Warning Letter to FairPriceMD Inc. after reviewing their websites (www.fairpricelabs.com, www.fairpricemd.com) and social media pages on July 21, 2020. The letter addresses the sale of an at-home sample collection kit, referred to as the "covid-19 home test kit" or "DROPTM SARS-CoV-2 virus ELISA IgG and IgM Self-Collection Test Kit," intended for COVID-19 serology testing.

The FDA determined this product is 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 product is deemed adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because FairPriceMD Inc. 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

## Related Officers

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

Company: https://www.keypedia.com/companies/fair-price-labs-inc/ea39a07b-3ded-44a5-813f-41aec92b85da

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