Batch Failures: Significant Risk Events; Challenging Investigation Opportunities

Today’s (4/25/2012) news from In-Pharmatechnologist.com (see full link below) highlights information from FDA’s 2011 Warning Letter dataset.   The article states that: “In fiscal 2011 the US Food and Drug Administration (FDA) sent biopharma manufacturing-related warning letters to 52 facilities. Close to half of these included an observation about failure to thoroughly...
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FDA Warning Letters Increase 155% from 2010 Levels

If you have any role within an FDA-regulated company, it is likely you are aware that the FDA has been much more focused on enforcement activities since 2008.    Alternatively, if you are involved at all with supply chain, manufacturing, quality assurance, quality control, regulatory affairs or other FDA compliance activities, you are likely intimately familiar with the FDA’s aggressive...
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New FDA Inspections’ Database — How Useful for FDA-Regulated Industry?

The new Inspections Database (http://www.fda.gov/ICECI/EnforcementActions/ucm222557.htm) is a positive step by FDA to provide further transparency for the public (and likely their Congressional representatives!) regarding enforcement actions and results across the country and rest of world. It is certain that the information will be of value to those parties that are interested in which...
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A Low Cost, Seven-Step Approach to Reducing FDA Enforcement Risk

August…   Summer…    Sun, sand and surf…    As the song goes:   “summertime and the living is easy…”    My hope is that all of you involved in quality and compliance are enjoying some time off with friends and/or family and getting a chance to read a good book on a quiet beach somewhere. Unfortunately, for FDA-regulated companies, the FDA does not appear to be...
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Urgency: Promise or Problem for FDA-Regulated Companies

A couple of months ago I was engaged in a brief, friendly dialogue with one of my close friends – a college buddy – about a current business imperative:   urgency.      My friend is a Senior Partner with a large, very well-known business consulting firm, and has responsibility for major projects within large pharmaceutical companies. As part of our regular communications, my friend...
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