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ASN-LABS sold unapproved and misbranded compounded drugs, specifically retatrutide and semaglutide, directly to U.S. consumers via its website in violation of Federal Food, Drug, and Cosmetic Act sections 505(a), 502(f)(1), 301(a), and 301(d). The company's retatrutide products lacked FDA approval and proper labeling with adequate directions for use, while its semaglutide products carried false or misleading claims. The violations were identified during an FDA inspection of the company's website (asn-labs.com) in August 2025, conducted by the Center for Drug Evaluation and Research.