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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.