Strategia Project Management, Inc.

Warning LetterOpen

Chris Mashburn Chief Operating Officer Strategia Project Management, Inc. 1000 Jorie Blvd. Suite 370 Oak Brook , IL 60523 United States info@microsure.comIssued Sep 28, 2021Center 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.

Violations2

Issue DateSep 28, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Strategia Project Management, Inc.
Location: Chris Mashburn Chief Operating Officer Strategia Project Management, Inc. 1000 Jorie Blvd. Suite 370 Oak Brook , IL 60523 United States info@microsure.com
FEI Number: N/A
Country: United States
Issue Date: September 28, 2021
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Strategia Project Management, Inc. was cited for selling an unapproved non-alcohol-based topical antiseptic product intended to mitigate, prevent, treat, diagnose, or cure COVID-19 and other serious infections, violating section 505(a) of the Federal Food, Drug, and Cosmetic Act by marketing an unapproved new drug. The company also misbranded the product in violation of sections 502(a) and (ee) of the FD&C Act and unlawfully introduced it into interstate commerce through its website (microsure.com) and social media platforms. The enforcement action was undertaken during the COVID-19 public health emergency, when the FDA prioritized urgent measures to protect consumers from unauthorized COVID-19 treatment products.

Strategia Project Management, Inc. FDA Warning Letter, September 28, 2021