FDA 483 - Integra LifeSciences Sales LLC - May 26, 2022

Integra LifeSciences Sales LLC in Cordova, TN, was cited for two observations during an FDA inspection from May 23-26, 2022. The firm failed to design procedures to prevent communicable disease risk, specifically by continuing to manufacture and release HCT/Ps despite environmental monitoring excursions. Additionally, the firm did not maintain records concurrently, evidenced by lost or missing human birth tissue allografts from their inventory system.