McNeil healthcare, Puerto Rico: FDA case study

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...

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Bibliographic Details
Published in:Communications of the IIMA 2013-08, Vol.13 (3), p.21
Main Author: Adis, Warren
Format: Article
Language:English
Subjects:
Case studies
Compliance
Congressional investigations
Consent decrees
Drugs
Enforcement
FDA approval
Good Manufacturing Practice
Health care industry
Inspections
Manufacturing
Mathematics
Nonprescription drugs
Officials and employees
Pharmaceutical industry
Pharmaceuticals
Product recalls
Quality control
Regulatory agencies
Studies
Violations
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Description
Summary: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. Keywords: FDA, CAPA, cGMP, enforcement, warning letters, pharmaceuticals.
ISSN:1543-5970
1941-6687