The QMN Weekly Bulletin

Devicemakers that were invited to but did not participate in the joint U.S.-Canadian pilot multipurpose audit program (PMAP) are a priority for FDA inspection, according to an agency director.

Devicemakers Steris and Cardinal Health are facing a class action lawsuit after surgical instruments at two hospitals were sterilized in hydraulic waste fluid from elevators rather than Steris cleaning solutions.

The FDA’s launch of Sentinel, an initiative designed to transform the agency’s postmarket surveillance, will likely not place additional regulatory burdens on devicemakers, according to an agency director.

Bayer HealthCare (BHC) announced that BHC's Consumer Care Division has achieved the necessary regulatory approvals to complete the acquisition of the Western over-the-counter (OTC) cough and cold portfolio of Topsun Science and Technology Qidong Gaitianli Pharmaceutical Co., Ltd by Bayer Healthcare Company Limited in China.

Brisbane-based Progen Pharmaceuticals Limited announced the "spin-out" of its manufacturing business as the wholly owned subsidiary company PharmaSynth Pty Ltd.

Cantel Medical, a provider of infection-prevention products, said its Minntech Corp. subsidiary will move all of its Dutch manufacturing operations to the United States.

A Virginia-based pharmaceutical company is opening a plant, creating 55 new jobs. Galexe Pharma Sciences, a subsidiary of Excela PharmSci Inc., is investing $8.6 million in the plant over the next three years.

CytoDyn has begun GMP manufacturing and humanization of Cytolin, a monoclonal antibody that uses the human immune system to control HIV infection.

Imtech will realise much of the technology in the CDPP project (Chemical Development Pilot Plant) in Geel for Janssen Pharmaceutica (part of the American pharmaceutical group Johnson & Johnson).