FDA EIR - Xo Biologix - January 05, 2024

An FDA inspection of Xo Biologix, a distributor of human tissue products, was conducted from January 3-5, 2024, in Austin, TX. This initial inspection, performed under regulatory guidelines for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), aimed to assess the firm's operations. While no formal inspectional observations (FDA 483) were issued, three significant issues were identified through discussions with management.

Firstly, the firm's FDA registration was inaccurate, failing to reflect its correct legal name, current contact information, and the specific tissue products it was distributing. Secondly, the Supplier Quality Agreement between Xo Biologix and its contract manufacturer lacked clarity regarding each party's responsibilities, particularly concerning the Instructions for Use for the MaviX product. Finally, the company was receiving Tissue Usage Records (TURs) but not actively reviewing them. This oversight led to the discovery of widespread off-label use of the MaviX product by practitioners, for purposes beyond its intended topical wound care application, including internal and injectable routes.

In response, Xo Biologix committed to promptly updating its FDA registration and revising its supplier agreement to clearly delineate responsibilities. Furthermore, management indicated they would begin reviewing TURs, communicate with distributors about the intended use of MaviX, and consider discontinuing sales to individuals or practices misusing the product.