FDA Warns Chinese Drug Company Over Sloppy Heparin Production

The Food and Drug Administration has issued a warning letter to a Chinese drugmaker over quality-control problems found during recent inspections at a factory that makes the blood thinner heparin for use in the United States.

The agency told Changzhou SPL Co. that during a six-day inspection of its plant in Wujin City in February FDA investigators uncovered various violations of U.S. manufacturing practices that could endanger consumers' health and safety.

SPL is a wholly owned subsidiary of Wisconsin-based Scientific Protein Laboratories.

The FDA said the inspection at the plant, about two hours west of Shanghai, was part of its investigation into how a contaminant ended up in Chinese-made heparin that has been linked to numerous adverse reactions and 81 deaths in the United States.

The agency has traced the contaminant to a dozen Chinese companies that shipped heparin to 11 nations, including the U.S. and Canada.

FDA inspectors found that the operators of the Wujin City plant could not verify that processing steps used there are effective in removing impurities from raw heparin later sent to the United States for final preparation and distribution, according to the letter.

The letter said that until SPL verifies its compliance with U.S. manufacturing specifications, the FDA retains the right to block the Wujin City factory's products from entering this country.

The agency said SPL inadequately evaluates the suppliers of heparin ingredients and uses materials from suppliers the company itself had designated as unacceptable, according to the letter.

The letter also chided SPL for using unsuitable and unclean manufacturing equipment.

The inspection team found dirty, scratched product preparation tanks that, although identified as clean by factory management, had "unidentified material" inside, according to the letter.

To comment, ask questions or contribute articles, contact West.Andrews.Editor@Thomson.com.