FDA 483 - Clive Ballard, M.D. - May 20, 2022
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 Clive Ballard, M.D., a clinical investigator in London, revealed significant issues with the conduct of a clinical study. Observations included the enrollment of ineligible subjects due to failure to follow the investigational plan and a failure to obtain proper informed consent from human subjects prior to study procedures. These findings indicate deficiencies in adherence to study protocols and regulatory requirements for human subject protection.
ID · 19b64d9e-ff02-4f2b-93ad-31278d12dea1