Stratus Biosystems, LLC dba CellGenuity Regenerative Science
FDA issued a warning letter to Stratus Biosystems, LLC dba CellGenuity Regenerative Science for manufacturing and distributing unapproved biological products — AmnioAMP-WJ™ (umbilical cord/amniotic membrane-derived) and AmnioAllograft (amniotic fluid-derived) — without a valid Biologics License Application (BLA) or Investigational New Drug (IND) application in effect. The products were marketed for broad non-homologous uses including orthopedics, neurology, cardiac, and oncology applications, disqualifying them from the 21 CFR 1271 section 361 exemption. FDA also documented extensive CGMP violations including unvalidated aseptic processes, inadequate environmental monitoring, sterility and endotoxin failures without investigation, and expiration dates assigned without stability testing. The letter demands a written response within 15 working days and warns that failure to comply may result in seizure and/or injunction.
Flagged claims (2)
PūRAMP PROCESSING preserves the products that can be used in a wide range of surgical and non-surgical applications.
PūrAMP SOLUTIONS DESIGNED FOR BROAD APPLICATIONS…NEURO/SPINE…ORTHOPEDICS…CARDIAC…ONCOLOGY… NERVES…
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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