XO Biologix, LLC

Selected passages from the FDA letter

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

Passage 1

your product is an unapproved new drug in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Your introduction or delivery for introduction of your product into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. § 331(d). Your product is also an unlicensed biological product in violation of section 351(a)(1) of the Public Health Service Act (PHS Act), 42 U.S.C. § 262(a)(1)(A).

Passage 2

your products are adulterated due to significant violations of current good manufacturing practice (CGMP) requirements identified at **(b)(4)**, including violations of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. § 351(a)(2)(B), and 21 CFR parts 210 and 211

Passage 3

the instructions for use (IFU) for your product indicates that “the tissue is processed and may be cut into predetermined size patches using sterile cutting tools.” This description implies that your product is provided as sheets when it is actually a liquid solution.

Passage 4

your certificate of analysis for your product states that the expiry period is five (5) years, while your IFU states that your product has a “3-year shelf life.” Neither of these statements about the stability of your product are supported with stability data.