FDA 483 - ARROW INTERNATIONAL, LLC - September 08, 2025

An FDA inspection of ARROW INTERNATIONAL, LLC in Morrisville, NC, revealed significant deficiencies in the firm's corrective and preventive action (CAPA) system. The company's CAPA procedures were found to be inadequate for addressing high-risk issues associated with Class I and Class II recalls, and CAPA activities were not adequately documented or implemented in a timely manner. These failures led to product design issues, such as cracking dilator hubs, and multiple patient complaints.