The QMN Weekly Bulletin

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.

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.

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.

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

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

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.

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

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

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