FDA 483 - WillowWood Global Llc - February 04, 2025

An FDA inspection of WillowWood Global Llc in Mount Sterling, OH, a medical device manufacturer, revealed significant and recurring deficiencies in its quality system. The firm failed to establish adequate procedures for corrective and preventive actions, complaint handling, supplier management, and rework of nonconforming products, with several issues being repeat observations from a prior inspection. Additionally, the company lacked proper controls for process revalidation, design changes, device master records, device history records, and failed to submit required information to the Global Unique Device Identification Database.