Next Medical Products Company, LLC – FDA Warning Letter, Dec 10, 2025

The FDA issued a Warning Letter to Next Medical Products Company, LLC following an inspection of its Branchburg, New Jersey facility from November 10 to December 10, 2025. The investigation revealed significant violations of the Quality System regulation (21 CFR Part 820) regarding the manufacture of various ultrasound gel products. Key issues include the company"s failure to maintain adequate environmental controls, evidenced by the dismissal of failed microbial test results without investigation. The firm also failed to establish robust Corrective and Preventive Action (CAPA) procedures, neglecting to address product nonconformities even after receiving complaints about contaminated, cloudy, or foul-smelling gel. Furthermore, the company implemented major design changes—specifically a significant preservative formula change and updated labeling—without performing required safety validations or obtaining necessary 510(k) clearance from the FDA. The agency also noted a failure to report a medical device correction to the FDA within the required 10-day window after the Center for Disease Control (CDC) confirmed bacterial contamination in several lots. Under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, the products are considered adulterated and misbranded. Next Medical Products Company must provide a written response within 15 business days outlining specific corrective actions to address these systemic failures. Failure to demonstrate a comprehensive plan for compliance may result in regulatory actions such as product seizures, injunctions, or civil penalties.