FDA 483 - Steven W. Pipe, M.D. - August 17, 2012

An FDA inspection of Steven W. Pipe, M.D., a clinical investigator in Ann Arbor, MI, revealed significant deficiencies in the preparation and maintenance of adequate and accurate case histories. Observations included discrepancies in recorded treatment volumes, unrecorded investigational drug dose changes, and inadequate training documentation for subinvestigators. These findings highlight issues with data integrity and record-keeping practices during clinical investigations.