FDA 483 - Next Medical Products Company, LLC - April 07, 2023

Next Medical Products Company, LLC in Branchburg, NJ, was inspected from March 28 to April 7, 2023, and received a Form FDA 483 with four observations. The inspection revealed significant deficiencies in process validation, including inadequate validation of water quality for ultrasonic gel products, insufficient monitoring procedures for water systems, and poorly documented design verification and cleaning validation studies. These issues indicate a lack of robust quality system controls for manufacturing medical devices.