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Mother Stem Institute, Corp. was warned for manufacturing and marketing stromal vascular fraction (SVF) derived from adipose tissue as an unapproved biologic drug product without proper FDA authorization or compliance with human cells, tissues, and cellular products (HCT/P) regulations. The company's website made unsubstantiated therapeutic claims for treating serious diseases including Alzheimer's disease, marketing the product as capable of transforming into lost cell types and providing preventative and therapeutic effects. The FDA identified these violations following a website review and the company's response to a records request regarding their enzymatic digestion processing method and intravenous administration of the SVF product.