FDA 483 - ITM Medical Isotopes GmbH - January 14, 2022

An FDA inspection of ITM Medical Isotopes GmbH, an API drug manufacturer in Garching B. Munchen, Bavaria, revealed significant deficiencies in quality system controls. Observations included incomplete training records, non-contemporaneous batch records, inadequate computer system security, and unclosed change controls. These issues indicate a need for improved documentation practices and data integrity.