BioStem Life Sciences
FDA issued a warning letter to BioStem Life Sciences (Pompano Beach, FL) on January 17, 2025, citing that its umbilical cord-derived and amniotic membrane products (OROPRO®, PROVISCUS®, NEOFYL®, and RHEO®) are unapproved biological drugs lacking a valid Biologics License Application (BLA), and that the products fail HCT/P criteria for minimal manipulation and homologous use. The letter also documents five significant CGMP violations covering environmental monitoring, cleaning validation, process validation, laboratory controls, and stability testing. FDA warned that failure to adequately respond may result in seizure and/or injunction.
Flagged claims (6)
The umbilical cord contains a collagenous matrix that is rich in hyaluronic acid, growth factors, and other cytokines. These elements are reported to have anti-inflammatory, anti-bacterial, and anti-scarring properties, making umbilical cord tissue an attractive biomaterial for use in an outpatient clinic or surgical procedures.
Instead of treating pain and injury with surgery and drugs, regenerative medicine supplements your body's own healing system with natural growth factors, cytokines, collagens, and other proteins. This array of components helps cushion and support damaged tissue and joints while providing structure and ideal microenvironment conditions for rebuilding.
RHEO® is a human perinatal tissue allograft derived from the extracellular matrix of the amniotic membrane. It is aseptically processed to preserve the endogenous cytokines, growth factors and scaffolding proteins present within the amniotic tissue matrix… By supplementing damaged tissue with these factors, you can stimulate the same scaffold creation naturally found in the body and allow the tissue to 'self-heal'.
Umbilical cord and Wharton's jelly allografts demonstrate anti-inflammatory, anti-bacterial and anti-fibrotic properties that support repair of damaged tissue.
Regenerative medicine harnesses your body's own ability to heal and boosts it in a very powerful and effective way.
Instead of treating pain and injury with surgery and drugs, regenerative medicine supplements your body's own healing system with natural growth factors, cytokines, collagens, and other proteins.
Required actions (3)
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.
Your responses do not describe actions you have taken or plan to take to address the impact of the above-described CGMP deficiencies on your distributed products that carry a (b)(4)-month shelf life and remain within expiry.
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