BioXtek LLC

The United States Food and Drug Administration (FDA) inspected your facility, located at the above address, between February 18, 2025, and February 26, 2025. During the inspection, FDA documented that your company manufactures products derived from human amniotic membrane, Sanoplast ECM and Sanoplast Duo, for allogeneic use (collectively, “your products”).

This letter is to advise you that 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). 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). A biological product for which a biologics license application (BLA) has been approved under section 351(a) of the PHS Act is not required to have an approved application under section 505 of the FD&C Act, 21 U.S.C. § 355; 42 U.S.C. § 262(j). Otherwise, with certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act. Your introduction or delivery for introduction of your products into interstate commerce, or the causing thereof, is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. § 331(d).

Based on information and records reviewed by FDA, including your website, https://bioxtek.com, (last visited November 2025), your products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans and/or are intended to affect the structure or function of the body. For example, in a video embedded on your website at https://bioxtek.com/about/, you indicate that your membrane patch products, including those derived from amniotic membrane, have the following applications:

• “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…”

Therefore, your products are drugs as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and biological products as defined in section 351(i) of the PHS Act,42 U.S.C. § 262(i).

Your Sanoplast ECM and Sanoplast Duo products are also human cells, tissues, or cellular or tissue-based products (HCT/Ps) as defined in 21 CFR § 1271.3(d) and are subject to regulation under 21 CFR part 1271, issued under the authority of section 361 of the PHS Act, 42 U.S.C. § 264. HCT/Ps that do not meet all the criteria in 21 CFR § 1271.10(a) are not regulated solely under section 361 of the PHS Act and theregulations in 21 CFR part 1271. Unless an exception in 21 CFR § 1271.15 applies, such products are regulated as drugs, devices, and/or biological products under the FD&C Act and/or the PHS Act and are subject to additional regulation, including applicable premarket review. Based on a review of relevant materials, BioXtek LLC does not qualify for any exception in 21 CFR § 1271.15, and your products fail to meet all criteria in 21 CFR § 1271.10(a).

For example, your Sanoplast ECM and Sanoplast Duo products fail to meet the criterion that the HCT/Ps be “intended for homologous use only.” Homologous use means that the “labeling, advertising, or other indications of the manufacturer’s objective intent” demonstrate that the HCT/P is intended to perform “the same basic function or functions in the recipient as in the donor.” 21 CFR §§ 1271.3(c) & 1271.10(a)(2). Your products are not intended solely to perform the same basic function or functions of the HCT/P in the recipient as in the donor (e.g., in the donor, amniotic membrane serves as a selective barrier for the movement of nutrients between the external and in utero environment, protecting the fetus from the surrounding maternal environment, and serving as a covering to enclose the fetus and retain fluid in utero). Rather, 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).

Therefore, these HCT/P are not regulated solely under section 361 of the PHS Act, 42 U.S.C. § 264, and the regulations in 21 CFR part 1271.1 See 21 CFR § 1271.20. In addition to being regulated under section 361 of the PHS Act and 21 CFR part 1271, your products are regulated as drugs as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and biological products as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i), as stated above.

Subject to certain exceptions not applicable here, to lawfully introduce or deliver for introduction into interstate commerce a drug that is a biological product, a valid BLA must be in effect under section 351(a)(1) of the PHS Act, 42 U.S.C. § 262(a)(1). Such licenses are issued only after showing that the product is safe, pure, and potent. Your products are not the subject of an approved BLA.

We have reviewed your response, dated March 18, 2025, to FDA’s Form FDA-483 in detail. We acknowledge your representation that you have corrected the deficiencies documented on the FDA-483. However, your response does not address the violations noted above.

This letter addresses certain issues regarding your products and is not intended to be an all-inclusive list of deficiencies that may exist in connection with your products. 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. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure full compliance with all applicable statutory and regulatory requirements.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address these matters may result in action without further notice including, without limitation, seizure and/or injunction.

Send your electronic response and any questions regarding this letter to CBER’s Office of Compliance and Biologics Quality, Division of Case Management at CBERDCMRecommendations@fda.hhs.gov.