Pinnacle Transplant Technologies, LLC
FDA issued a warning letter to Pinnacle Transplant Technologies, LLC (Phoenix, AZ) regarding its amniotic membrane and amniotic fluid-derived products, PalinGen®, which FDA determined are unapproved new drugs and biological products lacking required BLA or IND authorization. Promotional materials claimed the products support wound healing and tissue regeneration, triggering classification as drugs under the FD&C Act and biological products under the PHS Act. FDA also documented six significant CGMP deviations including failures in aseptic process validation, sterility failure investigations, and environmental monitoring. The letter warns that failure to adequately respond may result in seizure and/or injunction.
Flagged claims (3)
PalinGen (b)(4) contain[s] (b)(4) and "Amniotic tissue (b)(4)."
PalinGen® (b)(4) is intended, for example, for use in wound healing and tissue regeneration
your products are intended for use in the cure, treatment, or prevention of diseases or conditions, such as wound healing, and/or are intended to affect the structure or function of the body
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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