Frontier Biologics, LLC
FDA issued a warning letter to Frontier Biologics, LLC (Waco, TX) after a February–March 2024 inspection found that its human amniotic fluid and amniotic membrane allograft products are being marketed and distributed as unapproved new drugs and unlicensed biological products in violation of the FD&C Act and PHS Act. The company's marketing materials made therapeutic claims for wound healing, inflammation reduction, and orthopedic use without an approved BLA or active IND. FDA also cited six significant CGMP violations including failure to validate aseptic processes, inadequate environmental monitoring, and two uninvestigated sterility failures. The letter warns that failure to adequately respond may result in seizure and/or injunction.
Flagged claims (4)
[Purified Amniotic Fluid Allograft] Applications [include]: o Muscle Tears o Soft Tissue Injuries o Wounds, Acute and Chronic o Osteoarthritis o Joint Injuries / Pain
Allograft [Matrix]…Use: o … assists in wound healing, both chronic and acute. o … is used to enhance healing after a primary surgical repair.
Allograft [Matrix]…Benefits: o Catalyzes natural healing process to support proper remodeling o Provides specific signaling which lowers the body's inflammatory response o Mitigates formation of scar tissue
Purified Amniotic Fluid Allograft…can be applied directly at the site of injury, pain, or inflammation with a simple injection…Once introduced, it causes a systemic healing cascade in the body, targeting the site of injection.
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 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 response also does not address your specific plans for disposition of the inventory of Purified Fluid Allograft or Allograft Matrix at your facility that were manufactured under the conditions described in this letter. Further, your response does not address products that have been distributed and remain in the marketplace.
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