Chinese Vaccine Producer Faked Data Since 2014

FDA is working to ensure future valsartan active pharmaceutical ingredients are not at risk of N-nitrosodimethylamine (NDMA) formation

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The China State Council investigation team has reported Changchun Changsheng Life Sciences Limited had violated rules on vaccine production management and standards as early as April 2014.

This investigative task force said in a statement reported by XINHUANET on August 7, 2018, that they are pledging severe consequences for those convicted of criminal offenses and neglecting regulatory responsibilities.

The investigators said the company had used expired materials to reduce costs and falsified vaccine records to avoid regulatory scrutiny.

Approximately 18 people, including Changsheng Biotech chairwoman Gao Junfang and other executives from the vaccine maker, were arrested earlier. 

The investigation is ongoing, said the task force.

“We can rest assured that there will now be more unannounced inspections,” Dr. Gauden Galea, China representative for the World Health Organisation (WHO), told Reuters.

This vaccine scandal erupted after staff of China’s second-biggest rabies vaccine maker Changchun Changsheng Life Sciences, claimed that it was found forging production data and violating standards in making Vero-cell rabies vaccines.

These defective rabies vaccines have been recalled in both domestic and overseas markets, an official statement said.

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In addition to the rabies vaccine recall, Changchun Changsheng was found to have produced and distributed 252,600 doses of faulty DTaP vaccines that immunize toddlers and young children against whooping cough, diphtheria, and tetanus.

Separately, on August 6th, the US Food and Drug Administration (FDA) continued to publish updated lists of products included in the Chinese valsartan recall and the list of products not included in that recall.

The FDA first announced on July 13th the recall of non-expired products that contain the ingredient valsartan, supplied by Zhejiang Huahai Pharmaceuticals, Linhai, China. 

Valsartan is an angiotensin-II-receptor antagonist used to treat hypertension (high blood pressure), recent heart attack and heart failure.  

It is available on its own or in combination with other active substances.

FDA is working with drug manufacturers to ensure future valsartan active pharmaceutical ingredients are not at risk of N-nitrosodimethylamine (NDMA) in the formation.

NDMA is classified as a probable human cancer-causing substance.