根據(jù)FDA官網(wǎng)公布的消息，百特公司將支付由無菌產(chǎn)品不符合cGMP而引起的1800萬美元的罰款。違規(guī)內(nèi)容為：在生產(chǎn)期間，一個員工報告了高效過濾器有霉菌生長的情況。然而百特還是繼續(xù)在該潔凈室生產(chǎn)了幾個月的大容量無菌注射液，而且該過濾器還是一直被發(fā)現(xiàn)有霉菌生長。從后來FDA檢查發(fā)現(xiàn)該過濾器長有很多霉菌。
摘譯如下：
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.
美國司法部表示：百特醫(yī)療保健有限公司同意支付18158000美元解決因無菌藥品生產(chǎn)不符合cGMP而引起的刑事和民事責任。在一份刑事信息文件中，政府指責百特因沒有遵循cGMP生產(chǎn)這些藥品根據(jù)FDCA法案被認為摻假。
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.
百特在一個天花板上安裝有高效過濾(HEPA)器的潔凈室里生產(chǎn)大容量無菌注射液?？諝庥筛咝н^濾器進入潔凈室。信息透露，在生產(chǎn)期間，一個百特的員工向工廠經(jīng)理報告了高效過濾器有霉菌生長的情況。然而百特還是繼續(xù)在該潔凈室生產(chǎn)了幾個月的大容量無菌注射液，而且該過濾器還是一直被發(fā)現(xiàn)有霉菌生長。
Subsequent testing of the filters following an unannounced U.S. Food and Drug Administration (FDA) inspection revealed several mold species on the filters.
從后來FDA檢查的一份未對外公布對該過濾器的檢驗透露，該過濾器長有很多霉菌。
Baxter admitted that it distributed products in interstate commerce that were adulterated in violation of the FDCA.
百特承認了其違反FDCA。