百特因无菌产品不符合GMP被罚1800万美元

根据FDA官网公布的消息，百特公司将支付由无菌产品不符合cGMP而引起的1800万美元的罚款。违规内容为：在生产期间，一个员工报告了高效过滤器有霉菌生长的情况。然而百特还是继续在该洁净室生产了几个月的大容量无菌注射液，而且该过滤器还是一直被发现有霉菌生长。从后来FDA检查发现该过滤器长有很多霉菌。

摘译如下：

Healthcare company Baxter Healthcare Corporation (Baxter) has agreed to pay $18.158 million to resolve its criminal and civil liability arising from Baxter’s failure to follow current Good Manufacturing Practices (cGMP) when manufacturing sterile drug products, the Department of Justice announced today. In a criminal information filed today in the Western District of North Carolina, the government charged that, between July 2011 and November 2012, Baxter introduced into interstate commerce drugs that were adulterated under the Federal Food, Drug, and Cosmetic Act (FDCA) because Baxter did not follow cGMP when making those products.

美国司法部表示：百特医疗保健有限公司同意支付18158000美元解决因无菌药品生产不符合cGMP而引起的刑事和民事责任。在一份刑事信息文件中，政府指责百特因没有遵循cGMP生产这些药品根据FDCA法案被认为掺假。

At North Cove, Baxter manufactured large-volume sterile intravenous (IV) solutions in a clean room that had high-efficiency particulate absorption (HEPA) filters installed in the ceiling.Air was pushed into the clean room through the HEPA filters. As alleged in the information, during the relevant time period, a Baxter employee reported the presence of mold on the HEPA filters to plant management. However, Baxter continued to manufacture IV solutions in that clean room for months while the filters the employee had identified as moldy remained in place.

百特在一个天花板上安装有高效过滤(HEPA)器的洁净室里生产大容量无菌注射液。空气由高效过滤器进入洁净室。信息透露，在生产期间，一个百特的员工向工厂经理报告了高效过滤器有霉菌生长的情况。然而百特还是继续在该洁净室生产了几个月的大容量无菌注射液，而且该过滤器还是一直被发现有霉菌生长。

Subsequent testing of the filters following an unannounced U.S. Food and Drug Administration (FDA) inspection revealed several mold species on the filters.

从后来FDA检查的一份未对外公布对该过滤器的检验透露，该过滤器长有很多霉菌。

Baxter admitted that it distributed products in interstate commerce that were adulterated in violation of the FDCA.

百特承认了其违反FDCA。