FDA 483 - Amanda Unit, Heart and Chest Hospital, NHS Trust - September 28, 2012
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
- Inspection Date
- September 28, 2012
- Product Type
- Drugs
ID · 80454eae-5046-4c1c-9e6a-9cdc9010242a