When inspectors from the US Food and Drug Administration showed up at a Chinese company that supplies key ingredients to two of the top US drug companies, a curious thing happened.
After lunch, they walked into a quality control lab on the second floor, where they saw a worker pull what looked like a memory stick from a computer and put it in the pocket of his lab coat. The inspectors asked to see what he’d taken. The man turned and ran.
The FDA inspectors at Zhejiang Hisun Pharmaceutical Co. Ltd. (600267.CN) never found out what the worker took from the computer, but they found plenty of other things, according to agency documents describing problems at the company, obtained through a Freedom of Information Act request by Bloomberg.
There was evidence that quality control staff deleted records of tests that might show a drug was impure, the news agency said. Audit trails disappeared. A paper shredder was kept close by machines that recorded quality data.
The United States and the rest of the world are more dependent than ever on China for medicine.
Along with India, the country is one of the top two producers of base ingredients for drugs in the world, according to the Institute of Medicine.
But FDA inspections showed that many of the Chinese companies supplying key ingredients to top drug makers have plenty of violations that could put patients at risk.
In fact, the agency has barred 38 plants in China from exporting some or all of their products to the US for manufacturing violations, Bloomberg said.
At least 34 facilities are banned from exporting a blood thinning ingredient, after a past scandal, according to the FDA’s import alert list.
Among those Chinese manufacturers, Hisun is one of the largest and makes key components of everything from cholesterol to cancer medicines.
Its US customers include companies such as Hospira Inc., now owned by Pfizer Inc., and Merck & Co., which take raw ingredients and turn them into pills and vials for pharmacies and hospitals.
At least 15 of Hisun’s products were banned from US import in September.
Hisun said it’s working to fix problems at the plant, and confirmed the broad outlines of the report while declining to discuss each specific violation.
The company said it retested the samples in question and said they met standards.
“Hisun is maintaining further communication with the FDA, and actively pushing forward rectifications,” the company said in an e-mailed statement.
The company said the man fled over a misunderstanding caused by a language barrier, and that he took an electronic key used for one of the lab machines, not a data storage device.
Hisun isn’t alone in its violations of FDA rules.
During an August inspection of another drug ingredient manufacturer, Zhejiang Hisoar Pharmaceutical Co. Ltd. (002099.CN), FDA officials found that quality records had been deleted and test records been altered, with failing results sometimes going unreported, according to records obtained through another Freedom of Information Act request by Bloomberg.
Like Hisun, Hisoar makes ingredients for some of the world’s biggest brand-name drugmakers, including Pfizer and Novartis AG.
A 2012 stock exchange filing shows that Hisoar has a 20-year agreement to supply antibiotic products to Pfizer Asia Manufacturing Pte Ltd., a subsidiary of the New York-based drugmaker.
Hisoar declined to comment.
China’s drug regulatory body, China FDA, said it didn’t have an immediate comment on the violations or its relationship with the US agency. The FDA declined to comment beyond the inspection documents on Hisun or Hisoar.
Pfizer and Novartis both said they’re aware of the inspection at Hisoar, and were taking action to make sure products were up to quality standards, though didn’t provide specifics.
Pfizer said it makes sure products meet standards before reaching the market, and that Hisoar’s problems hadn’t affected the quality of Pfizer’s own products.
Pfizer also said it was aware of the inspection at Hisun, and there was no known impact on the quality of its drugs.
Merck can’t discuss supplier relationships, said Pam Eisele, a spokeswoman. The FDA declined to comment on Hisun’s customers or other details.
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