FDA did not issue any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators, From the archives, here is the Clinical Inspection Summary for eluxadoline, originally submitted by Furiex and now marketed by Actavis as Viberzi. Five sites, plus the sponsor and the CRO who provided the IXRS system for the study were inspected. Sites were selected for inspection on the basis of high enrollment, previous inspections, complaints and efficacy results. Inspections spanned three to twelve days. Two sites received 483s.
Dr. Alterbaum received a 483 for failing to follow the investigational plan and failing to report study changes to the IRB.
- During the course of the study, a monitor determined that study staff was entering data that was required to be entered by the subjects.
- FDA notes that Dr. Alterbaum removed the study staff, discussed the issue with the subjects and instituted corrective action.
Dr. Wilson received a 483 for enrolling an ineligible subject.
- A subject with an exclusionary lab value was enrolled. FDA notes that this was a known issue, and reported in the NDA line listings that the sponsor had submitted to FDA.