title: Final FDA inspection manual.
abstract: For some time now, the only publicly available compliance programme guidance manual on medical device inspections and administrative and enforcement activities has been a draft document. On 7 February 2001, a final guidance document was issued. This article discusses this document and its importance to non-US medical device manufacturers preparing for FDA facility inspections.
authors.affiliation: donawa@srd.it
authors.forename: M
authors.initials: M
authors.lastname: Donawa
mesh_terms: D004864:Equipment and Supplies / Q000592:standards*; D019983:Guideline Adherence; D017408:Guidelines as Topic; D007221:Industry / Q000592:standards*; D008370:Manuals as Topic; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration