The QMN Weekly Bulletin

HHS Secretary Mike Leavitt supports a Republican congressman’s efforts to give the FDA jurisdiction over criminal Federal Food, Drug and Cosmetic Act (FDCA) violations occurring outside the U.S.

Hiring additional inspectors for manufacturing facilities would be a top priority for the FDA if funding were available, Janet Woodcock, the agency’s deputy commissioner for scientific and medical programs, said at a recent congressional hearing.

GyNova’s sole employee has no documentation of any training on medical device regulations or current good manufacturing practices that would enable him to evaluate manufacturing and sterilization processes used for his firm’s product, according to a recent warning letter.

Germany’s medical regulator has asked companies selling the blood thinner heparin in Germany to test all batches of their product for contamination, the regulator said.

Strides Arcolab’s penicillin sterile manufacturing site in Bangalore has been classified as acceptable by the U.S. FDA for manufacturing sterile products for the U.S. market.

Ivax Pharmaceuticals, a member of Israel’s Teva group, is expected to triple drug production at its facility in north Moravia in what is the largest Israeli investment in the Czech Republic.

Alfa Laval has introduced new plate technology for the continuous production of pharmaceuticals, fine chemicals and speciality chemicals that has “the potential to start something of a revolution in the chemicals industry,” the Swedish company claims.

Good news for France is bad news for Terre Haute. Pfizer Inc. seriously considered opening a new inhaled medicines technology center in Terre Haute, a company spokesman said Monday.

Switzerland-based Nycomed says it is planning to move the vast majority of its raw material sourcing to India, a move which will result in the loss of around 200 jobs at sites in Germany and Austria.