# FDA WARNING_LETTER - Avazo-Healthcare, LLC - November 16, 2020

Source: https://www.keypedia.com/records/warning_letter/avazo-healthcare-llc/87328f2d-381b-4455-9fef-24511815d7aa

> FDA WARNING_LETTER for Avazo-Healthcare, LLC on November 16, 2020. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Avazo-Healthcare, LLC
- Inspection Date: 2020-11-16
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On November 30, 2020, the FDA issued a Warning Letter to CBD Market Web and COVID Test Shop, located at 605 Louis Dr Ste 502, Warminster, PA 18974. The letter addresses violations observed on their websites, https://www.covidtests.shop and www.cbdmarketweb.com, and associated social media pages, from August 21, 2020, through November 16, 2020.

The FDA found that the companies were selling unapproved and unauthorized COVID-19 test kits and CBD products with claims to mitigate, prevent, treat, diagnose, or cure COVID-19. Specifically, the "COVID-19 Ag Rapid Test Cassette" and "COVID-19 Coronavirus Spike Glycoprotein Antigen Ag Rapid Test Kit" were deemed adulterated under 21 U.S.C. § 351(f)(1)(B) and misbranded under 21 U.S.C. § 352(o) because they lacked FDA marketing approval, clearance, or authorization, and the firm failed to notify the agency of intent to introduce these devices into commercial distribution.

Additionally, serology test kits like the "COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma). FDA EUA." and "FDA EUA CE Approved Coronavirus (COVID-19

## Related Officers

- [Director](https://www.keypedia.com/people/donald-d-ashley/060f0dda-e6e8-4f9c-97e7-f540d523d902)
- [Associate Director](https://www.keypedia.com/people/serena-viswanathan/7d1b292d-1f22-42ff-8452-0bc9673b8326)
- [Director](https://www.keypedia.com/people/timothy-t-stenzel/c53bdcbc-5f38-4c82-b8fc-181624201c10)

Company: https://www.keypedia.com/companies/avazo-healthcare-llc/7f737c4c-6cd7-4d4d-9e8f-85cd4913099d

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