FDA 483 - Next Medical Products Company, LLC - December 10, 2025
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Next Medical Products Company, LLC, a manufacturer in Branchburg, NJ, was cited for significant quality system deficiencies during an FDA inspection. Observations included inadequate environmental controls, failures in corrective and preventive actions, and insufficient procedures for design changes. Most critically, the firm failed to report a recall for its Clear Image Ultrasound Scanning Gel, which was contaminated with Paraburkholderia bacteria and posed a risk to health.
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ID · 42b62a6c-fa44-4b31-a932-23595d2ef003