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Platinum Biologics LLC was cited for distributing four unapproved umbilical cord-derived and exosome products (Nano PRP Jelly, Nano Flex, NanoEx, and Nano Xsomes) for allogeneic use without required FDA approval, violating section 505(a) of the FD&C Act and section 351(a)(1) of the PHS Act. The company marketed these products through its website for therapeutic use in treating autoimmune disease, pain, depression, and connective tissue defects, thereby establishing them as drugs and unlicensed biological products without the required Biologics License Application (BLA) or new drug application approval. The FDA determined that these products cannot legally be introduced into interstate commerce without proper regulatory authorization.