BioXtek LLC
FDA issued a warning letter to BioXtek LLC (CEO Bruce R. Werber, DPM) in Pompano Beach, FL, after a February 2025 facility inspection found that its human amniotic membrane-derived products, Sanoplast ECM and Sanoplast Duo, are being marketed and distributed as unapproved new drugs and unlicensed biological products in violation of the FD&C Act and PHS Act. The products' website claims—including accelerating wound healing, tendon repair, nerve regrowth, and anti-fibrotic/anti-inflammatory effects—establish drug/biologic intent without an approved BLA. FDA warned that failure to address these violations may result in seizure and/or injunction, and required a written response within 15 working days.
Flagged claims (3)
They are used most notably for wound care. They accelerate the healing of wounds—diabetic wounds, third degree burns without any scarring.
Secondarily uses are in orthopedic uses for tendon repair and making little nerve tunnels to help nerves regrow or nerves to grow without scarring.
These membranes are very powerful anti-fibrotics so they stop scarring and they also provide [a] anti-inflammatory environment…
Required actions (3)
Please submit your response 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.
We advise you to comprehensively review your website and other labeling and marketing materials to ensure that you are lawfully marketing your products in full compliance with the FD&C Act, the PHS Act, and their implementing regulations.
Failure to adequately address these matters may result in action without further notice including, without limitation, seizure and/or injunction.
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