FDA 483 - Implants International Ltd. - December 18, 2023

An FDA inspection of Implants International, Ltd., a device manufacturer in Thornaby-on-Tees, revealed ten significant quality system deficiencies. The firm failed to adequately establish procedures for corrective and preventive actions, complaint handling, design risk analysis, incoming product acceptance, environmental controls, supplier management, non-conforming product control, process control for passivation, finished device acceptance, and design verification. These issues indicate a systemic breakdown in the firm's quality management system, particularly concerning their Rotoglide implant products.