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ABSTRACT
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.
Keywords: FDA, CAPA, cGMP, enforcement, warning letters, pharmaceuticals.
FOOD AND DRUG ADMINISTRATION CASE STUDY
The FDA is the supervisory agency that provides oversight and guidance to the bio- pharmaceutical (BP) industry. It safeguards the public by ensuring that BP products are safe, effective, and manufactured in accordance with current Good Manufacturing Practice (U. S. Food and Drug Administration, 2004a). This paper provides a case study of McNeil Consumer Healthcare and its main manufacturing facility at Ft. Washington, Pennsylvania, from 2000 to 2011. Over this 12-year period, the case study details FDA activities at this site. This includes plant inspections, Form 483 observational reports (483), and warning letters (WLs), as well as recalls and plant closures. While it would be premature to extrapolate from one case study to overall FDA performance, it is fair to say that certain insights can be gained concerning procedures, performance, oversight, and governance. Similarly, these findings about FDA performance provide an opportunity to review how its newly adopted risk methodology and quality assurance practices are incorporated into its oversight practices.
To put this case study into appropriate perspective, the findings were compared with other research that focuses on more quantitative studies of FDA performance using sector-wide data. The two principal academic investigations of FDA and quality assurance (QA) that we are aware of are Adis' risk studies (2007; 2008), and Marcher and Nickerson's (2006) review of quality systems. Both were sector evaluations, rather than a case study.
The McNeil Ft. Washington facility is noteworthy in that it posed significant compliance challenges to the FDA during the 12-year period. There were several FDA Field Alerts about...