The QMN Weekly Bulletin

Pacira Pharmaceuticals received an FDA Form 483 for inadequate sterilization procedures and poor recordkeeping practices at its San Diego manufacturing plant.

Oldsmar, Fla.-based Gulf Medical Fiberoptics violated device quality system (QS) regulations with flawed supply chain quality assurance and inadequate corrective and preventive action (CAPA) procedures, FDA investigators found during a recent inspection.

Health Canada is incorporating risk-based reviews into its facility inspections.

Australia’s biggest drug company CSL is trying to dampen the effect of criticisms made by the U.S. Food and Drug Administration of its manufacturing operations.

A major fire at a research and development facility of a pharmaceutical company in Sholinganallur on Sunday morning damaged computers, laboratory equipment and furniture.

The over-the-counter or prescription medication provided in the United States may not be as safe as consumers are led to believe, according to the research findings of Aleda Roth, the Burlington Industries Professor of Supply Chain Management at Clemson University.

AMRI announced the receipt of a letter from U.S. Food and Drug Administration regarding its Burlington, Mass.  aseptic finish-and-fill facility, acquired in June 2010.

The Aenova Group opened a new integrated production facility to enable the company to improve processes and increase production efficiency.

Director of Commerce of Washington State Rogers Weed joins CMC Biologics officials David Kauffmann and Gustavo Mahler at the CMC Biologics opening of its state-of-the-art biopharmaceutical manufacturing facility in Bothell.