| FDA檢查常見三種文件 |
FDA檢查常見三種文件
一、Form 483 #483表格 This form with the eponymous number 483 is used by the executing Inspector (FDA Investigator) to document the deficiencies he found. It is issued at the end of the inspection and should be answered officially. This response is expected within 15 working days after its issuance. Only then it is guaranteed that the statement will be taken into account in a possible Warning Letter (see below). Sometime, in the case of reasonable compliance, no 483 is issued. 483表格用于執(zhí)行檢查的檢查員（FDA調(diào)查員）記錄其所發(fā)現(xiàn)的缺陷。在檢查結(jié)果時(shí)檢查員要簽發(fā)該表格，受檢企業(yè)則需要對其中缺陷進(jìn)行正式回復(fù)。對該表格中缺陷的回復(fù)需要在其簽署后的15個(gè)工作日內(nèi)提交。只有在收到回復(fù)后，才會可能做出決定是否簽發(fā)警告信（見下）。有時(shí)，在達(dá)到合理符合的情況下，沒有483表格簽出來。 二、EIR: Establishment Investigation Report 工廠調(diào)查報(bào)告 The EIR is also created by the Inspector in addition to the form 483. This should be done within 30 working days. The EIR is then examined by the responsible Center or District Office of the FDA, issuing the following statuses: 除了483表以外，檢查員還要制作EIR。EIR要在30個(gè)工作日內(nèi)完成，然后交由FDA地區(qū)辦公室或中央辦公室負(fù)責(zé)人檢查，檢查后會被識別為以下幾種狀態(tài)： NAI: No Action Indicated - there were no objectionable items found during the inspection NAI：不需要采取措施---在檢查期間沒有發(fā)現(xiàn)違規(guī)項(xiàng)目 VAI: Voluntary Action Indicated - objectionable items were found, but no action is required on the part of the authority. All of the company's actions are on a voluntary basis. VAI：自愿采取措施---發(fā)現(xiàn)了違規(guī)項(xiàng)目，但不需要官方采取行動。公司的所有行為都是基于自愿的。 OAI: Official Action Indicated - objectionable items were found and further regulatory measures will be derived (e.g. Warning Letter). OAI：官方需采取行動—發(fā)現(xiàn)違規(guī)項(xiàng)目，需要采取進(jìn)一步法規(guī)措施（例如警告信） The EIR is forwarded to the inspected company. As part of the so-called 'Freedom of Information Act' it can also be requested by other companies, though. But experience has shown that the disclosure of a foreign EIR may take some time. FDA會將EIR發(fā)給受檢公司。作為所謂“信息自由法案”的一部分，其它公司也可以申請查看EIR。但經(jīng)驗(yàn)顯示公布國外EIR要花費(fèi)相當(dāng)長時(shí)間。 三、Warning Letter 警告信 This is mainly issued when serious defects were identified but also if the answer to the Form 483 is classified as inadequate. It is released - after a review by the responsible Center/ District Offices, not the Inspector himself. The company must respond within 15 working days and explain in detail how to resolve the deficiencies on the one hand and how a recurrence can be prevented on the other hand. Warning Letters are generally published on the homepage of the FDA. 如果檢查中發(fā)現(xiàn)了嚴(yán)重缺陷，且對483表格的回復(fù)被認(rèn)為是不充分的，則FDA會簽發(fā)警告信。公司必須在15個(gè)工作日內(nèi)進(jìn)行回復(fù)，詳細(xì)解釋如何解決這些缺陷，以及如果防止其再次發(fā)生。警告信一般在FDA官網(wǎng)上發(fā)布。 In the aftermath, other unpleasant consequences for the company may apply: 之后公司可能會面臨以下惡果： Influence on the approval 對批準(zhǔn)的影響 The authorisation for one or more products will not be granted. Applications will not be processed. 將停止頒發(fā)一個(gè)或多個(gè)藥品的批準(zhǔn)。停審申報(bào)資料。 Import Stop / FDA Import Alert 進(jìn)口中止/FDA進(jìn)口禁令 The company's product (or products) may no longer be imported into the United States. The goods remain at customs. 公司的產(chǎn)品可能不能再出口至美國。產(chǎn)品將被扣留在海關(guān)。 Debarment List 褫奪清單 This list comprises all persons who are not allowed to produce pharmaceutical products for the American market. The Debarment List is freely available. 該清單包括了所有不允許生產(chǎn)銷往美國的藥品的人員。褫奪清單是公開的。 Court - Consent Decree 法院---同意令 For American companies and its subsidiaries it can be obtained legally that for several months to years a consulting company will check the company and streamline systems and processes. A final inspection is carried out at the end. In the meantime, profits can be skimmed off. 對于美國公司及其分公司，可以能會需要有一個(gè)顧問公司對公司進(jìn)行幾個(gè)月到幾年的檢查，并改進(jìn)系統(tǒng)和流程。結(jié)束后會進(jìn)行檢查，同時(shí)會失去利潤。 |
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