# FDA WARNING_LETTER - Xo Biologix - January 05, 2024

Source: https://www.globalkeysolutions.net/records/warning_letter/xo-biologix/22b8160b-8f52-4e31-bd0d-50453694c778

> FDA WARNING_LETTER for Xo Biologix on January 05, 2024. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Xo Biologix
- Inspection Date: 2024-01-05
- Product Type: Biologics
- Office Name: Center for Biologics Evaluation and Research
- Summary: The FDA inspected the facility at 609 Castle Ridge Rd, Suite 400, Austin, TX, from January 3-5, 2024. The company markets and distributes MaviX™, an amniotic fluid-derived product. The FDA determined MaviX™ is an unapproved new drug, an unlicensed biological product, adulterated, and misbranded.

MaviX™ is an unapproved new drug under section 505(a) of the FD&C Act and an unlicensed biological product under section 351(a)(1) of the PHS Act because it lacks an approved Biologics License Application (BLA). Promotional materials and the company website claim MaviX™ "Helps reduce pain, inflammation, and regenerate tissue," and is "Anti-Inflammatory" and "Anti-Fibrotic," indicating drug and biological product intent.

The product is adulterated due to significant Current Good Manufacturing Practice (CGMP) violations, as detailed in Warning Letter CBER 25-679023, violating section 501(a)(2)(B) of the FD&C Act and 21 CFR parts 210 and 211. The firm is responsible for CGMP compliance regardless of manufacturing location.

MaviX™ is misbranded under section 502(a) of the FD&C Act. The Instructions for Use (

## Related Documents

- [EIR - 2024-01-05](https://www.globalkeysolutions.net/records/eir/xo-biologix/88a486ab-e536-4664-a78c-8d76f3174bf9)

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/melissa-j-mendoza/681d7777-4f19-4ecc-b31d-3272cb275c77)

Company: https://www.globalkeysolutions.net/companies/xo-biologix/733af757-6b13-401a-8abd-d8b5628ffd76

Office: https://www.globalkeysolutions.net/offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d