Jon E. Swanson
COO
Next Science LLC
10550 Deerwood Park Blvd. Ste 300
Jacksonville , FL 32256
United States
(b)(6)@nextscience.com
(b)(6)@nextscience.comFEI 3012271775Issued Feb 21, 2025Center for Devices and Radiological Health
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3012271775.
Violations6
Issue DateFeb 21, 2025
Product TypeMedical Devices
StatusOpen
Letter Details
Firm
Next Science LLC
Location
Jon E. Swanson
COO
Next Science LLC
10550 Deerwood Park Blvd. Ste 300
Jacksonville , FL 32256
United States
(b)(6)@nextscience.com
(b)(6)@nextscience.com
FEI Number
3012271775
Country
United States
Issue Date
February 21, 2025
Issuing Office
Center for Devices and Radiological Health
Product Type
Medical Devices
Status
Open
Summary
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.
Next Science LLC FDA Warning Letter, February 21, 2025
Talk to a Specialist