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FDA Clinical Inspection Summary: Juxtapid (lomitapide mesylate) submitted by Aegerion

FDA did not post any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week.  From the archives, here is the Clinical Inspection Summary for Juxtapid (lomitapide mesylate) submitted by Aegerion. Three sites plus the sponsor were selected for inspection. Sites were selected on the basis of enrollment. Site inspections lasted three to four days and the sponsor inspection took place over six days. One site received an FDA Form 483.

Prof. du Toit Theron was cited for:

  • Consenting subjects using an Informed Consent Document in the Afrikaans language when the IRB/IEC had only approved the consent in the English language.

A notable theme through all the inspection summaries is that the line listings provided the the BIMO investigator did not contain all adverse events. It is noted that the sponsor remedied this during the sponsor inspection and FDA was provided with the correct dataset.