Communications of the IIMA


This research analyzes the Food and Drug Administration’s (FDA) quality systems methodology through a detailed 12-year case study of McNeil Consumer Healthcare and its Ft. Washington, Pennsylvania manufacturing facility. This in-depth review, from 2000 to 2011, includes plant inspections reports, out-of-compliance findings, warning letters and a plant closure injunction. It then contrasts the specific findings of the McNeil case study with an analysis of overall FDA performance within the same sector of Finished Bio-Pharmaceuticals (BP). In addition, this case study pays particular attention to the role played by the FDA’s risk methodology in enhancing the overall inspection process and increasing its quality assurance.