genotyping

FDA Clinical Inspection Summary: Vizamyl submitted by GE Healthcare

FDA did not post any warning letters to Sponsors/Monitors/CROs, IRBs and Clinical Investigators this week. From the archives, here is the Clinical Inspection Summary from GE Healthcare. Of the five locations inspected, all were sponsor locations or sponsor vendors. 

The sponsor received a 483 for failing to monitor, specifically:

  • One site exceeded IRB-mandated enrollment limits without approval. Another site exceed the enrollment cap sixteen days before receiving approval to do so. 
  • The monitor failed to follow up when two sites did not submit the required IRB closure form
  • A subinvestigator performed two study related procedures (autopsy and geneotyping) and wasn't listed on the FDA Form 1572. At another site, one subinvestigator performed five autopsies and was not listed on the FDA Form 1572. 
  • Three subinvestigators at one site had not submitted financial disclosure forms.
  • At another site, two subinvestigators did not sign financial disclosure forms. FDA notes that aside from a one time reminder, the monitor did not follow up to collect the form for one subinvestigator. 
  • At one site, six of 10 ECGs were not performed within protocol specified timeframes