The QMN Weekly Bulletin

Genzyme used components and intermediates for the production of bulk Thymoglobulin lots that exceeded prespecified bioburden and pathogenic microorganism limits, according to an FDA warning letter.

As devicemakers move toward a global outsourcing model, firms should consider stockpiling supplies and product components because the FDA has come under pressure to bring foreign manufacturing sites into compliance, thereby raising the risks of import detention.

The FDA seized more than $300,000 worth of unapproved drugs, dietary supplements and their component ingredients manufactured by St. Louis-based General Therapeutics due, in part, to grossly unsanitary conditions at the company’s facilities.

China and the United States will seal a cooperation pact next month to enhance drug safety and Beijing will launch a new sweep against the false advertising of medicines, China’s drug watchdog said.

Thoratec publicized a worldwide recall of certain models of its implantable heart assistance devices distributed since October 2004.

A factory that will produce treatments for HIV/AIDS is opening in Uganda, the first of its kind in the country.

Singapore’s Univac Precision Engineering has expanded one of its Chinese factories to make a push into that country’s medical manufacturing market.

Union chiefs have slammed proposed job cuts at a drugs company, writes Kate Mead.

Domestic drug makers have agreed to withdraw 120 combination drugs — totaling over 270 brands — from the market.