McNeil Healthcare, Puerto Rico: FDA Case Study

Authors

Warren Adis, Iona College

Abstract

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.

Recommended Citation

Adis, Warren (2013) "McNeil Healthcare, Puerto Rico: FDA Case Study," Communications of the IIMA: Vol. 13: Iss. 3, Article 2.
DOI: https://doi.org/10.58729/1941-6687.1217
Available at: https://scholarworks.lib.csusb.edu/ciima/vol13/iss3/2