FDA 483 - Integra LifeSciences Corporation - July 02, 2018

Integra LifeSciences Corporation in Cincinnati, OH, was inspected and received a Form FDA 483 with four observations. The inspection revealed significant deficiencies in the firm's quality system, including inadequate procedures for corrective and preventive actions, complaint handling, product identification and traceability, and design change controls. These issues indicate a systemic failure to maintain proper quality management for medical devices.