FDA 483 - Marine Polymer Technologies - July 19, 2021

Marine Polymer Technologies, a medical device manufacturer in Topsfield, MA, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to establish adequate procedures for design control, specifically regarding the composition of design review teams and the completeness of Design History Files for its Syvek Excel Vascular Access Hemostasis System. These issues indicate a lack of robust controls over the design and development process for medical devices.