Ex-FDA Commissioner sentenced - Feb 28, 2007
Former FDA Commissioner Lester Crawford was sentenced to three years' supervised probation with fines of roughly $90,000 for lying about stocks he owned in companies regulated by the FDA while he was Commissioner. Crawford pled guilty in October to charges of having a conflict of interest and false reporting of his stock records. Don't we teach in GMP training that falsifying records will get you fired and sometimes even prosecuted? Guess Mr. Crawford wasn't practicing GMP.GMP Training Systems, Inc.www.GMPTrainingSystems.comServing 1057 clients since 1996Our next GMP Boot Camp is April 18 - 19
in Anaheim California. Learn more at
www.gmptrainingsystems.com/asp/public_workshops.aspPlease forward this post to others in your organization who might benefit.
Cardinal Health signs Consent Decree - Feb 20, 2007
FDA announced that Cardinal Health 303 Inc. formerly known as Alaris Medical Systems, Inc., and three of its top executives, have signed a consent decree for condemnation and permanent injunction related to their Signature Edition (SE) infusion pumps.
Cardinal Health 303 Inc. has agreed to stop manufacturing and distributing all models of the SE infusion pumps until they correct manufacturing deficiencies and until the devices are made in compliance with the current good manufacturing practice (CGMP) requirements and the Quality System (QS) regulation for medical devices.
Read FDA’s announcement and the actual Consent Decree.
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This is David Markovitz, President of GMP Training Systems, Inc. Surely you heard about the recall of Peter Pan Peanut Butter last week. I checked our pantry at home and found 5 jars with the code listed in the recall. This recall really hit home for us. 5 jars? Yes, we like peanut butter in our house (Peter Pan WAS our favorite).
GMP Training Systems, Inc.
www.GMPTrainingSystems.comServing 1054 clients since 1996Our audio seminar series - Reversed-Phase HPLC
Method Development: Generate Better Methods Faster –
is starting on March 2. Learn more at:www.gmptrainingsystems.com/asp/lc_series_070302.asp
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FDA Whistleblowers Help Congress - Feb 13, 2007
Scientists who have worked at the U.S. Food and Drug Administration and criticized agency decisions are now helping Congress fashion legislation to tighten product-safety rules.
The scientists include David Ross, who said in an interview that FDA supervisors forced him to retract a recommendation that the antibiotic Ketek, made by Sanofi-Aventis SA, was probably too dangerous to be used for treating two common respiratory infections. The drug was approved in 2004 and had $148 million in sales in 2005.
Ross is one of four current or former employees of the FDA who are working with Congress on bills intended to create more stringent drug safety rules.
Be prepared for tougher FDA inspections as a result of actions like this.
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GMP Training Systems, Inc.www.GMPTrainingSystems.comServing 1051 clients since 1996Last chance to register for our GMP Boot Camp.February 21 - 22 in Hampton, VA. Learn more atwww.gmptrainingsystems.com/asp/public_workshops.aspPlease forward this post to others in your organization who might benefit.
FDA 's Budget up 5% - Feb 6, 2007
The President’s FY 2008 Budget includes a 5 percent increase for FDA over the budget submitted to Congress last year. FDA's portion of the federal budget is $2.1 billion.
This means a bigger FDA next year to keep us on our toes.GMP Training Systems, Inc.www.GMPTrainingSystems.comServing 1047 clients since 1996Our first GMP Boot Camp in 2007 is filling up fast.February 21 - 22 in Hampton, VA. Learn more atwww.gmptrainingsystems.com/asp/public_workshops.aspPlease forward this post to others in your organization who might benefit.
