FDA 483 - New Wave Endo-Surgical, Corp. - February 17, 2023

An FDA inspection of New Wave Endo-Surgical, Corp. in Coconut Creek, FL, a manufacturer of the M-Close device, revealed significant deficiencies across its quality system. The firm failed to adequately establish and implement procedures for complaint handling, corrective and preventive actions, control of nonconforming product, supplier control, and design changes. These issues indicate a systemic breakdown in maintaining quality and regulatory compliance for their medical devices.