title: Evaluating out-of-specification laboratory results.
authors.affiliation: Division of Manufacturing and Product Quality, CDER/FDA, Rockville, MD 20855.
authors.forename: P F
authors.initials: PF
authors.lastname: Vogel
mesh_terms: D004345:Drug Industry / Q000592:standards*; D005069:Evaluation Studies as Topic; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration