Amnio Technology, LLC
FDA issued a warning letter to Amnio Technology, LLC (Phoenix, AZ) regarding its amniotic membrane and amniotic fluid-derived products, PalinGen® Flow® and PalinGen® InovōFlo®, finding them to be unapproved new drugs and biological products marketed without a valid Biologics License Application (BLA) or approved NDA. The company's promotional materials made wound healing, tissue regeneration, anti-inflammatory, and anti-microbial claims that triggered drug/biologic classification under the FD&C Act and PHS Act. FDA also documented significant CGMP deviations including lack of process validation, inadequate stability testing, and failure to report adverse events. The letter warns that failure to adequately respond may result in seizure and/or injunction.
Flagged claims (3)
Amniotic fluid possesses anti-inflammatory, anti-microbial and regenerative properties that make it attractive for use in clinical applications.
PalinGen Flow contain[s] key growth factors, cytokines, amino acids… hyaluronic acid, extracellular matrix proteins and cellular components recognized as intrinsic to the complex wound healing process
Amniotic tissue is a rich source of various biologically active factors involved in tissue regeneration and wound healing with reported anti-inflammatory, anti-bacterial, re-epithelialization and anti-fibrotic properties.
Required actions (3)
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 take to address any violations and prevent their recurrence.
Your response also does not adequately address the inventory you still have at your facility and your specific plans for the disposition of this product inventory.
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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