Covalon Technologies Inc.

Warning LetterOpen

Brian Pedlar CEO Covalon Technologies Inc. 1660 Tech Avenue, Unit 5 Mississauga ON L4W 5S7 Canada bpedlar@covalon.com cfredric@covalon.comFEI 3005004019Issued May 6, 2021Center for Drug Evaluation and Research

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3005004019.

Violations1

Issue DateMay 6, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Covalon Technologies Inc.
Location: Brian Pedlar CEO Covalon Technologies Inc. 1660 Tech Avenue, Unit 5 Mississauga ON L4W 5S7 Canada bpedlar@covalon.com cfredric@covalon.com
FEI Number: 3005004019
Country: Canada
Issue Date: May 06, 2021
Issuing Office: Center for Drug Evaluation and Research
Product Type: Drugs
Status: Open

Summary

Covalon Technologies Inc. was warned for marketing unapproved new drug products—non-alcohol based hand sanitizers—that were claimed to mitigate, prevent, treat, diagnose, or cure COVID-19, in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act. The company sold these products through its website (covaguard.com) and social media channels (Instagram and Facebook) without FDA approval or authorization, and the products were also misbranded under section 502(ee) of the FD&C Act. This enforcement action was issued during the COVID-19 public health emergency, when the FDA prioritized protecting consumers from unauthorized products making disease claims.

Covalon Technologies Inc. FDA Warning Letter, May 6, 2021