Neobiosis, LLC
FDA issued a warning letter to Neobiosis, LLC (Gainesville, FL), a manufacturer of amniotic fluid and umbilical cord-derived products, following a January–February 2023 inspection. The agency found that Neobiosis's products (Purified Amniotic Fluid, Wharton's Jelly Cellular, and Wharton's Jelly Acellular) are unapproved drugs and biological products marketed for wound healing and orthopedic uses without approved Biologics License Applications or active INDs, in violation of the FD&C Act and PHS Act. The firm also had significant CGMP deviations including unvalidated aseptic processes, inadequate environmental monitoring, and unsupported expiration dating. FDA warned that failure to adequately address these violations may result in seizure and/or injunction.
Flagged claims (4)
After my first round, I was able to completely come off of my opioid pain medication. I had made drastic healing progress in just 24 hours…I am beyond grateful to all of those at IMG and Neobiosis who have helped give me my life back.
it's used for orthopedic uses or for any other soft tissues…
these young tissues have the ability to transplant, the ability to heal…
it's like something just erased the injuries…her doctors were floored by her progress never seen wounds heal so quickly.
Required actions (2)
We request that you respond 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 lead to regulatory action without further notice. Such actions include seizure and/or injunction.
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