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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UPDATE: Free FDA GMP / QSR Ebooks for IPhone, IPad

This is an UPDATE to a post from May 2010. Please click this link for the original post. On Monday, June 21, Apple released the IPhone OS4.    This update to the Apple IPhone operating system added great new features such as multitasking, folders and more.    Also, along with this release, Apple released a great new application for the IPhone:   iBooks! From the Apple website: ...
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Webinar, June 23: Inspection Readiness for a More Aggressive FDA

Join the Center for Business Intelligence for a one-hour, information-packed webinar on managing FDA  inspections from a more aggressive FDA.   Now that pharmaceutical, medical device, dietary supplement, and biologics’ companies know that the FDA is back on the hunt for non-compliant companies, what can your company do about it? The short answer is be prepared! This webinar will...
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Two Billion, One Hundred Twenty Million Dollars – The Real Cost of Non-Compliance

I’m struggling to find an answer to the following question:   If you were the owner of a company, how much would you spend, year over year, to prevent a potential loss in market value to your company of two billion, one hundred twenty million dollars?     Would you spend a half-a-million dollars?   Five million?    Ten million?   How about twenty million?    Remember, we’re...
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