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FDA Joins Pilot Program To Boost Overseas Inspections

The U.S. Food and Drug Administration will join with European Union and Australian authorities to conduct overseas inspections, an area where the FDA has acknowledged it lacks resources.

Under the pilot program, the three governments will plan, allocate and conduct inspections of drug-manufacturing facilities, according to a news release Wednesday from the U.S. Department of Health and Human Services.

The inspections will initially focus on makers of ingredients active in drugs, but will expand to other manufacturing facilities if successful. Such active ingredients are more likely to create severe reactions than nonactive ingredients.

The FDA has come under intense criticism for its lack of overseas inspections after a widely used blood thinner was contaminated and imported from China earlier this year. The blood thinner, heparin, has been linked to more than 80 deaths in the U.S.

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