Flawed ingredients at China plant draw flak from drugmakers, warning from FDA

A single Chinese supplier was the focus of 61 complaints from various drugmakers, drawing warning letters from the U.S. Food and Drug Administration and bans on some of its products used as key components by other drugmakers.

Zhejiang Hisun Pharmaceutical, a joint venture with U.S. drugmaker Pfizer ($PFE), showed a "significant number" of complaints from customers, according to a Bloomberg News report. The complaints were laid out in an FDA warning sent to the company on the last day of 2015.

The company, based in Taizhou City in Zhejiang province, makes products that go into cholesterol and cancer drugs and was earlier banned from exporting at least 15 of its products to U.S. drugmakers after FDA personnel discovered company staff had deleted records of tests conducted on the materials and that other data like company audits had "disappeared," according to Bloomberg.

The FDA, for its part, said in its warning letter that "our concerns about deletion of data are heightened by the significant number of customer complaints for subpotency and out-of-specification (OOS) impurity levels from 2012-2014."

"We observed data deletion in your laboratory related to assay and impurity levels during this time period. During the inspection, we asked to review your lab's raw analytical data of the lots associated with four of the 61 complaints. However, you were unable to provide the raw data because it had been deleted. Without raw test data for the lots associated with these complaints, your firm could not adequately investigate the complaints, nor could you expand your investigation to determine whether other lots were affected by the same problems or take corrective actions, such as recalling drugs if appropriate."

The FDA said the company "could not adequately investigate the complaints" and said the company couldn't tell whether other lots of the products in question were affected and the company could not remediate the problem.

Chinese drugmakers and bulk suppliers are under the gun from international regulators because of quality control problems and outright fraud in some cases where company data was falsified.

The drug production sector in China--as well as India--has also caught the attention of U.S. lawmakers who have called for greater and more frequent inspections by the U.S. FDA, but China has balked at the attention and has, for example, refused to grant visas for additional FDA inspectors. The FDA, as of December, only had two inspectors in China to oversee 700 plants making drugs, according to Bloomberg.

Hisun told Bloomberg in December it was working to fix the problems and told the FDA it was hiring a third-party consultant to help it fix the problems, planned to set up user access restrictions on its data systems and would also upgrade its computer systems to beef up its audit trails.

The FDA said that wasn't enough and that "… simply activating audit trail functions and instituting password controls are insufficient to correct the broad data manipulation and deletion problems observed at your facility and to prevent their recurrence," the agency said in its warning letter.

- here's the FDA warning letter
- here's the report from Bloomberg

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