Communications of the IIMA


The McNeil case study examines the FDA’s quality assurance methodology through a detailed 12-year review of McNeil Consumer Healthcare, focusing on one of its major manufacturing facilities. It includes summaries from plant inspection reports, out-of-compliance findings, and warning letters for this period between 2000 and 2011. The results of this case study are then compared with a broader review of the FDA’s performance within the same sector of Finished Bio-Pharmaceuticals (BP) over a similar period. This analysis provides a perspective on how the FDA incorporates its risk methodology in the overall inspection process and in particular in its quality systems practices.