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July 11, 2008

Vol. 2 No. 28

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FDA Plans to Release ISO Audit Guidance Shortly

The FDA will release a draft guidance this month on how it will interpret International Organization for Standardization (ISO) audit reports when determining its inspection priorities for devicemakers, an agency director says. Read More

GE Details Benefits of Improved Quality System

Aside from bringing its operations into compliance with the FDA, GE Healthcare’s efforts to remediate production issues under a consent decree for its surgical imaging business have resulted in more efficient manufacturing operations and improved product quality, according to a company executive. Read More

Unreported Labeling Change Draws Warning Letter

Chattem failed to report a labeling change intended to reduce the risk of burns, skin removal and skin irritation with its Icy Hot Heat therapy patches, earning it a warning letter. Read More

Bristol-Myers Settles Clean Air Violations

Pharmaceuticals maker Bristol-Myers Squibb Co. has agreed to spend $3.65 million to resolve federal Clean Air Act violations by eliminating ozone-depleting refrigerants at factories in six states and Puerto Rico. Read More

GSK Transfers Paroxetine Production to Romania

British giant GlaxoSmithKline (GSK), leader of the local pharmaceutical market, which acquired the Europharm plant in Brasov in 1998, will start exports of Paroxetine this year, an antidepressant which will find its way from the Brasov plant to over 80 countries. Read More

A Chile First: Inspectors Shut Down Pharmaceutical Lab

Chile’s Public Health Institute (ISP) shut down pharmaceutical distributor BestPharma after years of quality and safety concerns. Read More

Introgen Cuts 29 Percent of Jobs

Introgen Therapeutics Inc. is reducing its development staff to focus on regulatory review and commercial activities. Read More

Judge Orders Drug Manufacturer to Pay $10 Million

A federal judge ordered a drug manufacturer that operated a plant in South Carolina to pay $10 million in connection with fraud. Read More

Vitro Opens New Manufacturing Facility

Vitro Diagnostics, dba Vitro Biopharma, announced the opening of a new corporate facility in the Coors Technology Center located in Golden, Colorado. Read More