# FDA WARNING_LETTER - pomegranate consulting, llc, pomegranate consulting, ltd.  - August 17, 2020

Source: https://www.keypedia.com/records/warning_letter/pomegranate-consulting-llc-pomegranate-consulting-ltd/18a388c6-28f0-4371-8bab-1e75340b70eb

> FDA WARNING_LETTER for pomegranate consulting, llc, pomegranate consulting, ltd.  on August 17, 2020. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: pomegranate consulting, llc, pomegranate consulting, ltd. 
- Inspection Date: 2020-08-17
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On August 18, 2020, the FDA issued a Warning Letter to DxAllergy Solutions, LLC, regarding the sale of an unapproved "COVID-19 test package" on www.elizabethyarnell.com. The FDA reviewed the website on August 17, 2020, and found the product offered for direct sale to consumers for at-home use, intended for COVID-19 mitigation, prevention, treatment, diagnosis, or cure.

The product is deemed a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act). It 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 device into commercial distribution, as required by section 510(k) of the Act (21 U.S.C. § 360(k)). The introduction or delivery of this product into interstate commerce is prohibited under section 301(a) and

## Related Officers

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

Company: https://www.keypedia.com/companies/pomegranate-consulting-llc-pomegranate-consulting-ltd/717917db-08c9-4ae5-958b-5aee35392b56

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