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FDA Warning Letter Explorer
FDA warning letter · Biologics

BioXtek LLC

Issued · Posted by FDA

FDA published a close-out letter on Feb 19, 2026. The passages below are from the original warning letter.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

your products are unapproved new drugs in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a).

Passage 2

Your products are also unlicensed biological products in violation of section 351(a)(1) of the Public Health Service Act (PHS Act), 42 U.S.C. § 262(a)(1).

Passage 3

your products are intended for certain wound care applications, including by accelerating the healing of wounds, that is not a basic function of amniotic membrane in the donor. Therefore, Sanoplast ECM and Sanoplast Duo fail to meet the criterion for homologous use. 21 CFR § 1271.10(a)(2).

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 1271.10(a)
  • 21 CFR 1271
  • 21 CFR 1271.15
  • 21 CFR 1271.3(d)
  • 21 CFR 1271.3(c)
  • 21 CFR 1271.10(a)(2)
  • 21 CFR 1271.1
  • 21 CFR 1271.20