FDA 483 - ITM Medical Isotopes GmbH - March 20, 2024

An FDA inspection of ITM Medical Isotopes GmbH in Garching B. Munchen, Germany, a manufacturer of pet drugs and sterile radioactive APIs, revealed significant deficiencies in their quality system. The firm failed to conduct adequate investigations into product failures and market complaints, particularly concerning product breakthrough prior to expiration. Additionally, the inspection found incomplete or inadequate written quality assurance procedures for recalls, OOS results, method validation, processing, calibration, and shipping validation.