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Next Science LLC was cited for manufacturing and distributing wound gels (SURGX® and BLASTX®) and wound irrigation solutions (XPERIENCE® and Bactisure®) without required FDA marketing authorization. The company violated the Federal Food, Drug, and Cosmetic Act by failing to obtain either a premarket approval (PMA) or investigational device exemption (IDE), and by not submitting the required 510(k) notification for commercial distribution. An FDA inspection conducted in August-September 2024 at the Jacksonville, Florida facility determined the products were adulterated and misbranded due to these missing authorizations.