FDA 483 - Amanda Unit, Heart and Chest Hospital, NHS Trust - September 28, 2012

An FDA inspection of Amanda Unit, Heart and Chest Hospital, NHS Trust in Liverpool, United Kingdom, revealed significant deficiencies in the conduct of a clinical study and the maintenance of adequate records. Observations included failures to follow the investigational plan and protocol, such as improper spirometer use and missing blood samples, as well as inadequate documentation for study drug dispensing. These findings indicate a need for improved oversight and record-keeping practices in clinical trial conduct.