A Chinese manufacturer of antibiotics sold in the U.S. hid quality testing results that may have indicated product contamination, the latest evidence of data manipulation at firms that make ingredients used by large pharmaceutical companies.
The U.S. Food and Drug Administration told Zhejiang Medicine Co. to hire a consultant and investigate “the extent of the inaccuracies in data records and reporting” on quality assurance, according to a warning letter dated Aug. 4 that was released Tuesday. The drugmaker was ordered to conduct a “risk assessment of the potential effects of the observed failures,” according to the letter.
The letter hasn’t had a “substantial impact” on production or operations, and active pharmaceutical ingredient exports remain “normal,” Ye Weidong, a representative of the company, based in Zhejiang province’s Shaoxing city, said by e-mail on Wednesday. The company said last week in a statement to the Shanghai stock exchange that it will rectify and reform practices at the problem site and will meet the FDA’s compliance deadline.
Drug inspectors have been cracking down on Chinese manufacturing plants as their ingredients are used in more medications sold in the U.S. More than 80 percent of U.S. drug ingredients are now produced abroad, mainly in China and India. The FDA has added 15 Chinese plants this year to its list of 54 factories that are banned from sending product to the U.S. Zhejiang Medicine hasn’t been added to the list.
