# FDA WARNING_LETTER - LVWellness & Aesthetics - October 15, 2020

Source: https://www.keypedia.com/records/warning_letter/lvwellness-aesthetics/3182473e-d885-41c5-9618-774c61dbf73b

> FDA WARNING_LETTER for LVWellness & Aesthetics on October 15, 2020. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: LVWellness & Aesthetics
- Inspection Date: 2020-10-15
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On October 15, 2020, the FDA issued a Warning Letter to LVWell, LLC, following a review of their websites (www.lvwell.com and www.facebook.com/lvwellnessaesthetics/) since August 5, 2020. The FDA observed the sale of products claiming to mitigate, prevent, treat, diagnose, or cure COVID-19, which are unapproved, adulterated, and misbranded.

Specifically, the "COVID-19 ANTIBODY TEST KIT" is cited as an adulterated device under section 501(f)(1)(B) of the FD&C Act (21 U.S.C. § 351(f)(1)(B)) due to the lack of an approved premarket approval (PMA) or investigational device exemption (IDE). It is also misbranded under section 502(o) (21 U.S.C. § 352(o)) for failure to notify the agency of intent to introduce the device into commercial distribution. The FDA emphasizes that no COVID-19 serology test for at-home use has been approved, cleared, or authorized.

Additionally, the "ViraFend Multi-Virus Defense" product is identified as an unapproved new drug sold in violation of section 505(a) (21 U.S.C. § 3

## Related Officers

- [Director](https://www.keypedia.com/people/timothy-t-stenzel/c53bdcbc-5f38-4c82-b8fc-181624201c10)
- [Director](https://www.keypedia.com/people/william-a-correll/f9e634a2-8e56-4c9b-984c-304f0c7db122)

Company: https://www.keypedia.com/companies/lvwellness-aesthetics/5609cf76-e58c-43b4-8ad3-9f436264b971

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