Tuesday, February 20, 2007

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.
Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.

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.com
Serving 1054 clients since 1996

Our 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

Please forward this post to others in your organization who might benefit.