Katherine Eban

“the mystery was far from solved. Nobody understood why heparin—which is made from the mucosal lining of pig intestines, most of which come from China—was suddenly making patients sick. In February 2008, the FDA discovered the likely source of the contamination: a Chinese plant supplying crude heparin to Baxter. In a clerical blunder, the FDA had completely overlooked and failed to inspect the facility, Changzhou SPL, located about 150 miles west of Shanghai. Instead, it inspected and approved a plant with a similar-sounding name. Predictably, once FDA officials finally traveled to Changzhou in February 2008 to make an on-the-ground inspection, they found serious problems. The facility had dirty manufacturing tanks and no reliable method of removing impurities from heparin, and it acquired the crude heparin from workshops that had not been inspected. Chinese regulators were no help at all. A loophole in Chinese regulations allowed certain pharmaceutical plants to register as chemical plants, which made them subject to far less oversight. For U.S. congressional investigator David Nelson, whose committee was now immersed in the heparin crisis as well, the situation laid bare the “classically good reason to be suspect of production coming from any country that doesn’t have competent regulatory authority.” The FDA issued an import alert in March 2008, meaning that Changzhou SPL’s shipments would be stopped at the U.S. border. Though”
― Katherine Eban, Bottle of Lies: The Inside Story of the Generic Drug Boom