根據(jù)FDA官網(wǎng)公布的消息，百特公司將支付由無(wú)菌產(chǎn)品不符合cGMP而引起的1800萬(wàn)美元的罰款。違規(guī)內(nèi)容為：在生產(chǎn)期間，一個(gè)員工報(bào)告了高效過(guò)濾器有霉菌生長(zhǎng)的情況。然而百特還是繼續(xù)在該潔凈室生產(chǎn)了幾個(gè)月的大容量無(wú)菌注射液，而且該過(guò)濾器還是一直被發(fā)現(xiàn)有霉菌生長(zhǎng)。從后來(lái)FDA檢查發(fā)現(xiàn)該過(guò)濾器長(zhǎng)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(guó)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(wú)菌藥品生產(chǎn)不符合cGMP而引起的刑事和民事責(zé)任。在一份刑事信息文件中，政府指責(zé)百特因沒(méi)有遵循cGMP生產(chǎn)這些藥品根據(jù)FDCA法案被認(rèn)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(gè)天花板上安裝有高效過(guò)濾(HEPA)器的潔凈室里生產(chǎn)大容量無(wú)菌注射液。空氣由高效過(guò)濾器進(jìn)入潔凈室。信息透露，在生產(chǎn)期間，一個(gè)百特的員工向工廠經(jīng)理報(bào)告了高效過(guò)濾器有霉菌生長(zhǎng)的情況。然而百特還是繼續(xù)在該潔凈室生產(chǎn)了幾個(gè)月的大容量無(wú)菌注射液，而且該過(guò)濾器還是一直被發(fā)現(xiàn)有霉菌生長(zhǎng)。
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(lái)FDA檢查的一份未對(duì)外公布對(duì)該過(guò)濾器的檢驗(yàn)透露，該過(guò)濾器長(zhǎng)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(rèn)了其違反FDCA。