XO Biologix, LLC

Warning LetterOpen

David P. Janice Chief Executive Officer and Owner XO Biologix, LLC 609 Castle Ridge Rd, Suite 400 Austin , TX 78746 United States (b)(6)FEI 3015521757Issued Dec 12, 2024Center for Biologics Evaluation and Research (CBER)

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Violations1

Issue DateDec 12, 2024

Product TypeDrugs

StatusOpen

Letter Details

Firm: XO Biologix, LLC
Location: David P. Janice Chief Executive Officer and Owner XO Biologix, LLC 609 Castle Ridge Rd, Suite 400 Austin , TX 78746 United States (b)(6)
FEI Number: 3015521757
Country: United States
Issue Date: December 12, 2024
Issuing Office: Center for Biologics Evaluation and Research (CBER)
Product Type: Drugs
Status: Open

Summary

XO Biologix, LLC marketed and distributed MaviX™, an amniotic fluid-derived product, as an unapproved new drug and unlicensed biological product in violation of the Federal Food, Drug, and Cosmetic Act and Public Health Service Act. The company's product was also found to be adulterated due to significant violations of current good manufacturing practice (CGMP) requirements under 21 CFR parts 210 and 211, with manufacturing and quality control deficiencies identified at an unspecified contract manufacturer. Additionally, MaviX™ was determined to be misbranded under FD&C Act section 502(a). The FDA prohibited the company from introducing or delivering the product into interstate commerce.

XO Biologix, LLC FDA Warning Letter, December 12, 2024