FDA WARNING_LETTER - Next Science, LLC - September 05, 2024

On February 21, 2025, the FDA issued a Warning Letter to Mr. Swanson following an inspection from August 12 to September 5, 2024, of his firm in Jacksonville, Florida. The firm manufactures wound gels (SURGX®, BLASTX®) and wound irrigation solutions (XPERIENCE®, Bactisure®).

The FDA determined that XPERIENCE®, BLASTX®, and SURGX® products are adulterated under section 501(f)(1)(B) and misbranded under section 502(o) of the Federal Food, Drug, and Cosmetic Act. The firm lacks approved applications for premarket approval (PMA) or investigational device exemptions, and did not notify the FDA of intent to introduce these products into interstate commerce as required by section 510(k).

The firm is marketing XPERIENCE®, BLASTX®, and SURGX® with claims and indications for use that were not cleared or approved by the FDA, constituting major changes in intended use requiring new marketing applications. These claims, particularly those related to "XBIO® Technology" and biofilm disruption, also raise jurisdictional issues, potentially subjecting the products to drug requirements under CDER.

Additionally, the inspection revealed Quality System Regulation (QSR) violations under 21 CFR Part 820, rendering the products adulterated under section 501(h). Specific violations include: 1. Failure