CI racks up 17-item 483 for lost and missing informed consent docs in vaccine study. (Clinical investigators).

Eddy Hsueh, M.D., John Wayne Cancer Institute, Santa Monica, CA, Los Angeles District

Clinical investigator Eddy Hsueh, M.D., received a whopping 17-item 483 following his initial FDA inspection in March 2002, though he inherited the Stage III and IV study from another investigator.

According to FDA records, the study--which appeared to be conducted with a vaccine--was transferred to Hsueh in February 2000, from Glen Tisman, M.D., who started the investigation in 1998. FDA investigator Ronald Koller of the Los Angeles district conducted the audit.

Hsueh, based at John Wayne Cancer Institute, Santa Monica, CA, failed to report several adverse events …