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.
"McNeil, Ft. Washington: FDA Case Study,"
Communications of the IIMA: Vol. 12
, Article 2.
Available at: http://scholarworks.lib.csusb.edu/ciima/vol12/iss3/2