North American Hirudin Biotech Products Inc.

Warning LetterOpen

Zengxun An President North American Hirudin Biotech Products Inc. 2531 Broadway, Suite A Everett , WA 98201 United StatesFEI 3010612715Issued Apr 21, 2021Office of Regulatory Affairs

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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 3010612715.

Violations1

Issue DateApr 21, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: North American Hirudin Biotech Products Inc.
Location: Zengxun An President North American Hirudin Biotech Products Inc. 2531 Broadway, Suite A Everett , WA 98201 United States
FEI Number: 3010612715
Country: United States
Issue Date: April 21, 2021
Issuing Office: Office of Regulatory Affairs
Product Type: Drugs
Status: Open

Summary

North American Hirudin Biotech Prodcts Inc. was cited for marketing unapproved drug products ("Hirudin" and "Red 65") through multiple websites without proper FDA authorization. The company's websites made numerous disease-treatment claims—including blood-thinning, cholesterol reduction, viral/bacterial defense, arthritis treatment, and anticoagulant therapy—that established the products as drugs under the Federal Food, Drug, and Cosmetic Act, yet the company had not obtained required New Drug Applications or demonstrated compliance with applicable regulations. The violations involved introducing these misbranded drug products into interstate commerce through online sales channels.

North American Hirudin Biotech Products Inc. FDA Warning Letter, April 21, 2021