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Article: Supplier control: growing regulatory concern for outsourcing.(Risk Management)
- Article from:
- Medical Product Outsourcing
- Article date:
- July 1, 2009
- Author:
CopyrightCOPYRIGHT 2009 Rodman Publishing. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Step back with me for a moment ... to 2007. The Dow Jones Industrial Average was happily climbing from 12,000 to 14,000, Bear Steams and Lehman Brothers were successful going concerns, Al Gore received a Nobel Peace Prize, and the Red Sox won their second World Series (yes, I live in Boston, Mass.). Life was simpler then, wasn't it?
Plus Ca Change ...
However, even in the white-picket-fence world of 2007, trouble was brewing. In that year, 52 percent of the U.S. Food and Drug Administration's (FDA) warning letters included a mention of supplier issues. From 2006 to 2007, FDA warning letters with purchasing control deficiencies increased 31 percent ...