# FDA WARNING_LETTER - DermaCare Biosciences, LTD. - December 01, 2021

Source: https://www.keypedia.com/records/warning_letter/dermacare-biosciences-ltd/4f2d890f-44a5-4cf2-bece-9612cfa933d1

> FDA WARNING_LETTER for DermaCare Biosciences, LTD. on December 01, 2021. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: DermaCare Biosciences, LTD.
- Inspection Date: 2021-12-01
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On December 1, 2021, the FDA issued a Warning Letter to Easy Rapid Now and Dermacare Packaging Private Label, citing the sale of adulterated and misbranded COVID-19 products. The FDA reviewed the companies' websites (easyrapidnow.com, dermacarepkg.com) and social media (LinkedIn, Facebook, Instagram) on multiple dates in 2021.

The "Easy Rapid Now COVID-19 Nasal Swab Antigen Test (Colloidal Gold)" is deemed a device under the Federal Food, Drug, and Cosmetic Act, intended for COVID-19 mitigation, prevention, treatment, diagnosis, or cure. However, it is offered for sale in the U.S. without FDA marketing approval, clearance, or authorization. This renders the product adulterated under section 501(f)(1)(B) of the Act, as there is no approved premarket approval (PMA) or investigational device exemption (IDE).

Furthermore, the product is misbranded under section 502(o) because the firm failed to notify the FDA of its intent to introduce the device into commercial distribution, as required by section 510(k). The introduction or delivery of this product into interstate commerce is prohibited under section 301(a), and any act making it misbranded while held for sale after interstate shipment is prohibited under section 301(k).

The

## Related Officers

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

Company: https://www.keypedia.com/companies/dermacare-biosciences-ltd/92ab09c6-0f04-4ecb-b0e6-8312585bd111

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