FDA did not post any warning letters this week to Sponsors/Monitors/CROs, IRBs or Clinical Investigators. From the archives, here is the Clinical Inspection Summary for Velphoro (21) submitted by Vifor Fresenius Medical Care Renal Pharma France. Three sites were selected for inspection and all inspections lasted 4 days based on enrollment and contribution to efficacy effect. One site received a FDA form 483.
Doctoer Hootkins was cited for:
- Failure to conduct the study according to the investigational plan.
- Two ineligible subjects were enrolled into the study
- Protocol required dose adjustments were not performed for eight subjects
- Serious Adverse Events (SAEs) were not reported for eight subjects
- Personnel were added to the delegation of authority log without documentation of training
- Seven subjects did not have vital signs obtained in the method required by the protocol
- Seven subjects did not have blood draws in the correct order of events at study visits