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Theqmnweeklybulletin

March 28, 2008

Vol. 2 No. 13

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Medtronic Recovers From Recall With Quick Shipping by UPS

When Medtronic recalled its entire line of Sprint Fidelis implantable cardioverter defibrillator leads, UPS established operations at the firm’s Puerto Rico manufacturing facility while the devicemaker aggressively transitioned production lines to its older Sprint Quattro leads. Read More

FDA Setting Up Shop in China

The FDA is establishing three permanent offices in China to monitor device, drug and food safety that will be staffed by eight FDA employees along with five Chinese nationals to assist them. Read More

Contract Sterilizer Cited by FDA

Isotron, a contract sterilizer of various medical devices, was cited by the FDA for changing specifications to processes via deviation or concession reports without conducting design control and validation testing, according to a warning letter. Read More

Heparin Scare Spreads in Europe

France, Italy and Denmark are the latest countries to recall heparin products as the contamination scare spreads over materials linked to China. Read More

Progen Restructures Manufacturing, Drug Discovery Divisions

Progen Pharmaceuticals Limited announced that it will outsource the commercial manufacture of PI-88. Read More

Lilly Contract Fuels BioConvergence Expansion

BioConvergence expects to create as many as 170 new jobs by 2011 as it grows its drug development and logistics services, the Bloomington company said. Read More

BioReliance Opens Tokyo Labs

BioReliance has opened a commercial office in Tokyo to take advantage of new business in Asia. Read More

West Pharmaceutical to Close Erie Plant

West Pharmaceutical Services Inc. has announced that it will close its Erie Industrial Park location as part of a larger restructuring and consolidation plan. Read More

Cleaning Validation Issues for Combination Devices

Manufacturers of medical devices or of pharmaceuticals or biologics know that establishing a cleaning validation protocol is a challenge. Read More