FDA 483 - Next Medical Products Company, LLC - October 04, 2021

Next Medical Products Company, LLC, a manufacturer of ultrasound gels in Branchburg, NJ, was cited for significant quality system deficiencies. The inspection revealed issues across multiple areas, including inadequate process validation, lack of change control procedures, premature release of finished devices, and deficiencies in device master records and equipment calibration. Additionally, the firm failed to adequately establish statistical techniques, evaluate suppliers, ensure auditor independence, and maintain a complete medical device reporting procedure.