Questions emerge on China's drugs
FDA inspectors observed a number of suspicious behaviors at Zhejiang Hisun Pharmaceutical Co. in China, which supplies key ingredients to major U.S. drug companies.
FDA inspectors observed a number of suspicious behaviors at Zhejiang Hisun Pharmaceutical Co. in China, which supplies key ingredients to major U.S. drug companies. Agency documents describe evidence that quality control staff deleted records of drug purity tests, audit trails vanished, and there was a paper shredder near machines that recorded quality data. Data integrity is a vital part of FDA's inspections in China, as patients are at serious risk if drugs do not meet quality standards. China is one of the world's top producers of base ingredients for drugs, and FDA has prioritized inspections there. So far, FDA has barred 38 Chinese plants from exporting some or all of their products to the U.S. due to manufacturing violations, and 34 facilities are banned from exporting a blood thinning ingredient. At least 15 products from Hisun were banned from U.S. import this year, but the company says it is working to fix problems at its plant. Pharmaceutical firms Pfizer and Novartis have said they were taking action to ensure their products were up to quality standards.