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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CAPA – The Untold Story

Try as I might in my consulting work, I can never seem to get away from CAPA.    As much as I would like to help companies prospectively improve their process control;   embrace better quality system integration and document design;   assess and implement computer-based quality systems; and use process risk analysis to rationalize quality system decisions and improve inspection outcomes...
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