Platinum Biologics LLC
FDA's Center for Biologics Evaluation and Research issued a warning letter to Platinum Biologics LLC (Orlando, FL) on August 15, 2025, citing four products — Nano PRP Jelly, Nano Flex, NanoEx, and Nano Xsomes — as unapproved new drugs and unlicensed biological products under the FD&C Act and PHS Act. The products, derived from umbilical cord tissue and exosomes, were marketed for allogeneic use to treat conditions including autoimmune disease, pain, depression, connective tissue repair, shoulder injuries, and heart failure without an approved Biologics License Application. FDA warned that failure to address violations may result in seizure and/or injunction, and required a written response within 15 working days.
Flagged claims (2)
intended for healing, the repair of age-related and trauma related defects in connective tissue, shoulder injuries, and heart failure
intended for use in the treatment of autoimmune disease, pain, depression, and the repair of age-related and trauma-related defects in connective tissue
Required actions (2)
Please submit your response in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence.
Failure to adequately address these matters may result in action without further notice including, without limitation, seizure and/or injunction.
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