title: Preparing for and handling the results of regulatory inspections of biomedical facilities.
abstract: Although there have been numerous presentations on how to conduct and survive a government inspection, it appears that these sessions do not always adequately include suggestions from those who have been the subjects of regulatory inspections. This paper will include comments from the experience of one of the regulated. Remarks apply to experience with U.S. regulatory authorities, principally the U.S. Food and Drug Administration (FDA) and the U.S. Environmental Protection Agency (EPA). This paper attempts to give guidance on how to prepare for an inspection and what to do at the debriefing and after the inspector(s) leave your facility.
authors.affiliation: Utah Biomedical Test Laboratory, 520 Wakara Way, Salt Lake City, Utah 84108, USA.
authors.forename: J B
authors.initials: JB
authors.lastname: Townsend
mesh_terms: D003142:Communication; D004282:Documentation; D017598:Efficiency, Organizational; D005161:Facility Regulation and Control / Q000458:organization & administration* / Q000592:standards; D005568:Forms and Records Control; D007324:Institutional Management Teams / Q000458:organization & administration*; D007373:Interinstitutional Relations; D007753:Laboratories / Q000592:standards*; D014481:United States; D014484:United States Environmental Protection Agency / Q000592:standards; D014486:United States Food and Drug Administration / Q000592:standards