China's drug regulator launches nationwide investigation into vaccine producers - China - Tibetol

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China's drug regulator launches nationwide investigation into vaccine producers
update:July 26,2018
July 26,2018-- China's drug regulator launched a thorough investigation into all vaccine producers across the country on Wednesday.
From July 25, teams will be dispatched to thoroughly investigate the whole process and entire chain of vaccine production of all vaccine producers, the State Drug Administration (SDA) announced Wednesday.
The investigation is conducted after an earlier examination of 45 vaccine producers that began at the beginning of the year, and follows an illegal vaccine production case revealed recently.
Changchun Changsheng Life Sciences Limited, a Chinese vaccine maker, was subject to an unannounced inspection by the SDA and Jilin provincial food and drug bureau on July 6 and July 8 following a tip-off.
On July 15, the SDA announced that the company had illegally produced freeze-dried human rabies vaccines after a comprehensive investigation the same day.
The inspection found that the company had fabricated production and inspection records, and arbitrarily changed process parameters and equipment during its production of freeze-dried human rabies vaccines.
The SDA had revoked the company's drug GMP certificate following its serious violations of relevant law and regulations, and demanded a recall of unused vaccines.
The SDA said that none of the batches of human rabies vaccines examined during the recent unannounced inspection have left the factory and are not sold on the market.
"All the inspected vaccines are under control," the agency said.
In October 2017, two batches of DPT vaccine produced by the Changchun Changsheng Life Sciences Limited and Wuhan Institute of Biological Products Co., Ltd were found to be defective. All the DPT vaccines involved have been sealed up and recalled by the two companies.
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