FDA 483 - Dr. Heino Enn Arpo, Clinical Investigator - November 24, 2006

The FDA inspected Dr. Heino Enn Arpo, a Clinical Investigator in Tallinn, Estonia, for bioresearch monitoring. The inspection revealed a failure to prepare and maintain adequate and accurate case histories. Specifically, a subject's severe diarrhea was not documented on the Case Report Form as required by the study protocol for adverse events.