The QMN Weekly Bulletin

Instituting adequate component acceptance procedures should be part of the strategy device manufacturers employ to reduce their number of product recalls, Michael Verdi, senior recall coordinator for the Center for Devices and Radiological Health, recommended.

Almost a year after the FDA announced its action plan for postmarket transformation at the Center for Devices and Radiological Health (CDRH), the agency is making progress on several “immediate priority actions” identified last November.

The pharmaceutical industry lags behind the food and beverage industry in measures of production efficiencies, leaving significant room for firms to improve manufacturing operations, according to a study prepared by enterprise manufacturing software firm Informance International.

As part of a plan to save up to $2 billion by the end of 2008, Pfizer announced it intends to close its manufacturing operations in Sandwich, England.

Boston Scientific is making progress on efforts to resolve a corporate warning letter from the Food and Drug Administration (FDA) but doesn’t see it being lifted by year’s end, a company official said.

Pharmaceutical giant GlaxoSmithKline says the nearly $200 million expansion of its Canadian-based influenza vaccine production facility is approaching completion.

Pfizer is notifying health-care professionals in the United States about the presence of a contaminant in the HIV medicine Viracept, the same drug Roche recently recalled in Europe after contaminated batches were discovered there.

Aptuit, a Greenwich, Conn.-based drug-development services firm, has acquired the chemical and pharmaceutical development business of a German firm, according to the company.

Sigma-Aldrich announced its intent to invest in a site northwest of Shanghai, China, for its new Asia-Pacific manufacturing hub.