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# XO Biologix Marketing Unapproved, Adulterated Drug
- URL: https://www.fdaweb.com/xo-biologix-marketing-unapproved-adulterated-drug/
- Published: 2025-01-08T12:00:00.000Z
- Updated: 2026-09-14T14:50:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158450

A 1/3-1/5/2024 FDA inspection at XO Biologix in Austin, TX, determined that the company markets and distributes a product derived from amniotic fluid under a redacted contract. A just-released 12/12/2024 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xo-biologix-llc-697717-12122024?ref=fdaweb.com) says the company’s MaviX product is an unapproved new drug and an unlicensed biological product.

MaviX also is adulterated, the letter says, due to significant violations of current good manufacturing practice (CGMP) requirements that were outlined in another [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xo-biologix-llc-697717-12122024?ref=fdaweb.com).

Finally, FDA says the product is misbranded because the labeling‘s instructions for use are false and misleading.

XO Biologix was told to respond with a list of specific steps it has taken to address any violations and prevent their recurrence, with documentation showing that the matters have been addressed and a schedule for completing the corrections.