483
Louise Charest, M.D.FDA 483 - Louise Charest, M.D. - September 29, 2017
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.
Record Details
An FDA inspection of Clinique Medicale L'Actuel, a clinical investigator, revealed a significant deficiency in obtaining legally effective informed consent. A subject in a clinical trial was administered study drug and underwent related tests after signing an informed consent form for a different study protocol. This lapse resulted in the subject participating in the study without appropriate consent.
Open in Dashboard
ID · e10780aa-2f8f-45db-b5f4-65ec0cd061b7