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Since joining ISPE just two years ago, my professional life has become much more fulfilling. I have made numerous business contacts because of the great networking opportunities. ISPE has kept me in touch with the latest in global regulatory affairs and I'm learning something new everyday from the Baseline® Guides. As a consultant, this has allowed me to provide my clients with the most up-to-date and relevant information available.

Gopal Nair, CEO
GRASP Enterprise, India

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FDA
Consequences of Non-Compliance with FDA

Recalls: FDA, Industry Cooperate to Protect Consumers
This article from FDA Consumer explains what recalls are, when they are used, how they are carried out, and how FDA works with industry in the event of a recall to protect consumers.

FDA Recall Policies
This article published by FDA's Center For Food Safety and Applied Nutrition, explains FDA's role in a recall, and the policies it uses.

Information on Recalls of FDA Regulated Products
This page publishes information that FDA provides on recalls, including guidance for industry..    

Inside FDA: Barring People from the Drug Industry
This article from FDA Consumer explains the process of debarring people from the drug industry.  This is a practice whereby FDA forbids people (or firms) convicted of certain crimes--basically, crimes related to FDA's regulation of drugs--from participating in the drug industry.

Debarment List
This page lists people who have been debarred, or legally excluded from working in the drug industry due to crimes they have committed.

Warning Letters and Untitled Letters to Pharmaceutical Companies (2007)
This page links to warning letters and untitled letters issued to pharmaceutical companies in the year 2005.  Some letters have been redacted or edited to remove confidential information.

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