Resources for Food and Drug Administration (FDA)

FDA Cites Problems at Chinese Plant Making Blood Thinner

www.washingtonpost.com

The Chinese plant at the center of a controversy over the safety of half the nation's supply of the blood thinning drug heparin had problems involving impurities, the quality and use of its equipment, and overall quality control, a preliminary inspection by the Food and Drug Administration found.

In a heavily redacted report made public yesterday, the FDA inspectors also described at least one instance of the company using active ingredients -- which are made from pig intestines -- supplied by a "workshop" deemed to be "unacceptable." Heparin made from that source, the report said, was marketed to the United States.

Also yesterday, the maker of the drug, Baxter International, recalled virtually all of its remaining heparin products. Earlier this month, the firm stopped production, but the FDA wanted to keep the existing Baxter heparin in doctors' hands because it did not want to cause a shortage of the life-saving drug. Agency officials said increased production by the other heparin manufacturer can now satisfy the demand.

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