McNeil, a Johnson & Johnson Subsidiary FDA Case Study

Abstract

This case study provides a detailed five-year review of one of Johnson & Johnson’s important subsidiaries, McNeil Consumer Healthcare. The research presents summaries from the Food and Drug Administration (FDA) inspection reports, out-of-compliance findings, and warning letters for the period between 2007 and 2011. It also relies on a class action lawsuit and a judicial consent decree within this timeframe to further understand the relationship between Johnson & Johnson and McNeil. The case study focusses on problems in the manufacturing and quality assurance at McNeil, and how Johnson & Johnson may have exacerbated McNeil’s production failures.