长春一公司违法违规生产冻干人用狂犬病疫苗被立案调查
青岛希尼尔翻译咨询有限公司（www.sinosenior.com）整理发布 2018-7-16
青岛希尼尔翻译公司（www.sinosenior.com）2018年7月16日了解到：A
vaccine producer in Northeast China’s Jilin province is under
investigation for law violations in producing rabies vaccines for human
use, China’s top drug regulator announced on Sunday.
国家药品监督管理局15日发表声明称，中国东北部吉林省一药品生产商因违法违规生产冻干人用狂犬病疫苗已陷入调查。
Changchun Changsheng Bio-tech Co, in Changchun, was found to have
serious irregularities, including fabricating production records in the
manufacture of rabies vaccines for human use, during an inspection by
the State Drug Administration, the administration said in a statement.
该涉事企业为长春长生生物科技有限责任公司(下称长春长生)。国家药品监督管理局在发布的一项声明中称，其存在生产记录造假等严重违反《药品生产质量管理规范》行为。
The administration conducted an unannounced inspection of the company
after being tipped off regarding suspected irregularities, it said. The
statement did not mention when the inspection took place.
随即，国家药品监督管理局组织对长春长生开展飞行检查，调查时间也未经披露。
No products involved in the inspection were on sale, and all the
vaccines involved have been removed, it said.
所有涉事批次产品尚未出厂和上市销售，全部产品已得到有效控制。
The State administration ordered Jilin Provincial Drug Administration to
suspend production of rabies vaccines, it said. The provincial
administration has sent an investigation team to the company, it said.
吉林省食品药品监督管理局调查组已进驻该企业。国家药品监督管理局已责令其停止狂犬疫苗的生产，
The State Drug Administration will continue to put its priority on drug
safety and impose the strictest supervision to ensure public safety in
the use of drugs, it said.
并承诺其始终将用药安全放在首位，主动采取最严监控措施，确保公众用药安全。
来源:中新网
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