The initial distributor is the foreign manufacturer's official correspondent with the FDA. With regards to the GMP, this initial distributor is responsible for maintaining complaint files and general record keeping requirements. A procedure shall be established and maintained for receiving, reviewing, and evaluating complaints. All complaints, including oral complaints, are to be processed in a uniform and timely manner. These complaints shall be evaluated to determine whether or not they require reporting to FDA under 21 CFR part 804 or 803, Medical Device Reporting. The initial distributor is also required to evaluate all complaints to determine whether an investigation is necessary, as well as complying with all other requirements in 820.198, Complaint Files. See Chapter 15 in this manual for more complete guidance on handling complaints.
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Yesterday was the deadline for all complaints。
昨天是所有抱怨的最后期限。
Yesterday was the deadline for all complaints.
昨天是所有抱怨的最后期限。
Please direct all complaints to Head Office.
请把意见讲给总公司听。
"We are trying our best to address all complaints that we are receiving and the soonest, the better from our point of view,".
VOA: standard.2009.08.23
The Election Complaints Commission, a U.N.-funded watchdog, is ordering all ballots from suspect polling stations recounted and audited.
VOA: standard.2009.09.09
But the U.N.-backed Election Complaints Commission is ordering a significant recount of ballots from every province covering 10 percent of all polling stations.
VOA: standard.2009.09.15
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