Viraldine, LLC

Warning LetterOpen

Viraldine, LLC 311 Lake Street Elmira , NY 14901 United States infor@viraldine.comIssued Mar 7, 2022Center for Drug Evaluation and Research | CDER

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Letter Details

Firm: Viraldine, LLC
Location: Viraldine, LLC 311 Lake Street Elmira , NY 14901 United States infor@viraldine.com
FEI Number: N/A
Country: United States
Issue Date: March 07, 2022
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Viraldine, LLC was cited for selling non-alcohol-based antiseptic products on its website that were marketed to mitigate, prevent, treat, diagnose, or cure COVID-19, violating section 505(a) of the Federal Food, Drug, and Cosmetic Act by distributing unapproved new drugs. The products were also found to be misbranded under section 502(ee) of the Act. The FDA and FTC jointly reviewed the company's website in December 2021 and March 2022, and the agency issued this warning during the declared national emergency for COVID-19 as part of urgent efforts to protect consumers from unauthorized COVID-19 treatment products.