Last September, U.S. regulators faced a dilemma: whether to allow importation of drug ingredients from a Chinese factory with a history of poor quality controls, or face shortages of treatments for American cancer patients.
Six months earlier, visiting Food and Drug Administration inspectors had uncovered what the agency later called “broad data manipulation” at the factory, located in Taizhou, about 200 miles south of Shanghai. Information about the potency and purity of some product batches had been deleted, making it difficult to investigate a significant increase in customer complaints, the FDA said in a warning letter to the plant’s owner, Zhejiang Hisun Pharmaceutical Co.
