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NuVida Medical LLC distributed four unapproved human tissue-derived products (Procenta, XCELLERATE, completeFT1, and Coll-E-Derm) without required FDA approval, violating section 505(a) of the FD&C Act and section 351(a)(1) of the PHS Act by marketing unlicensed biological products intended for disease treatment or prevention. During an FDA inspection in February 2025, the agency identified that the company was introducing these human cells, tissues, and cellular products (HCT/Ps) into interstate commerce without either an approved New Drug Application or a Biologics License Application. The company's website and promotional materials demonstrated clear intent-of-use claims that positioned the products as therapeutic agents rather than non-drug tissues, triggering regulatory requirements the company had failed to meet.