Chinese drugmaker hid data which may show contamination: US Food and Drug Administration
A Chinese manufacturer of antibiotics sold in the US 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 US 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 August 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.
Zhejiang Medicine has a contract that ends next year to supply Pfizer Inc.’s Hospira unit with the main ingredient for vancomycin, a widely used antibiotic, according to the Chinese company’s annual report.
The FDA letter didn’t say which drugs were affected by flaws in testing records. Pfizer hasn’t seen any issue with the products supplied by Zheijiang Medicine, Rachel Hooper, a Pfizer spokeswoman, said in an e-mail. The New York drugmaker has a programme to ensure all drugs meet its quality standards before they reach the market, Hooper said.
A telephone call outside of business hours to Zhejiang Medicine wasn’t answered.
Zhejiang Medicine unofficially tested drug ingredients for certain chemicals and recorded results in a folder marked “R&D,” the FDA said.
Those unofficial results, which were left out of the company’s quality control records, may indicate “the presence of unknown and uncharacterized impurities (including potential contaminants) in your drugs,” the agency said. The firm also backdated worksheets for impurity tests by several days, according to the letter.
Drug inspectors have been cracking down on Chinese manufacturing plants as their ingredients are used in more medications sold in the US.
More than 80 per cent 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 US.
Zhejiang Medicine hasn’t been added to the list. Zhejiang Medicine had about US$715.7 million in 2015 revenue, data showed. Its shares, which trade in Shanghai, were suspended earlier this week.