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# Multiple Violations in Next Science Inspection
- URL: https://www.fdaweb.com/multiple-violations-in-next-science-inspection/
- Published: 2025-04-01T12:00:00.000Z
- Updated: 2026-09-14T14:56:41.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158934

An 8/12-9/5/2024 FDA inspection at Next Science LLC in Jacksonville, FL, determined that the firm is illegally manufacturing and distributing adulterated and misbranded wound gels and wound irrigation solutions. A just-released 2/21 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/next-science-llc-698114-02212025?ref=fdaweb.com) says the medical devices are adulterated because the firm does not have an approved PMA or IDE application in place for them and misbranded because it did not notify the agency of its intent to introduce them into interstate commerce for commercial distribution. The letter says each of the firm’s three products at issue received 510(k) clearances but are being marketed for uses outside the scope of the clearances.

The letter says the inspection also identified these Quality System and Medical Device Reporting regulation violations:

- failure to establish and maintain procedures for validating the device design to ensure that devices conform to user needs and intended uses and include testing of production units under actual or simulated use conditions, and include risk analysis where appropriate;
- failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
- failure to adequately establish and maintain procedures for implementing corrective and preventive action; and
- failure to submit a Medical Device Reporting report to FDA no later than 30 days after receiving or otherwise becoming aware of information from any source reasonably suggesting that a device the firm markets may have caused or contributed to a death or serious injury.

Next Science was told to promptly correct the violations and to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with documentation of the steps and a schedule for completing the corrections.