FDA 483 - Marianne Wamboldt, M.D. - March 19, 2009

The FDA inspected Marianne Wamboldt, M.D. at The Children's Hospital in Aurora, CO, regarding clinical investigator activities. The inspection revealed that investigations were not conducted in accordance with signed protocols, leading to incomplete subject records for a diagnostic tool. Additionally, investigational drug disposition records were found to be inadequate, with missing documentation and discrepancies in drug quantities.