旅行散记七---- 郁闷483

玉兰

<p>9月25日</p>
<p>&nbsp;</p>
<p>今天很郁闷~~~<br/><br/>两周前和我的10位同事来到重庆,每天睡眠不足5小时,工作象是打仗~<br/><br/>四天前开始接受美国FDA和欧洲药监局的联合检查,检查的是我们重庆的工厂~<br/><br/>本来这个工厂是生产药品的起始原料,不属于药品的GMP管理的范畴~<br/><br/>从检查的第二天开始,美国FDA的检查官员通知我们,经过和他们华盛顿总部的磋商,他们将按照API(药品活性成分)工厂的要求来进行检查~<br/><br/>API工厂意味着不仅仅要符合中国的GMP,还要符合美国FDA以及欧洲的相关规定,,,,<br/><br/>检查与今天中午结束了,结果可想而知,我们拿到了美国FDA的483报告~<br/><br/>一共是5条整改意见~[em53]<br/><br/>郁闷!<br/><br/>现在是抓紧时间睡一觉,,晚上和大家一起讨论如何回答FDA的483~~~<br/></p>

[此贴子已经被作者于2008-9-25 17:33:07编辑过]

玉兰

<span class="bold">FDA Form 483 and Warning Letter</span><br/><br/>
<div style="FONT-SIZE: 14px">No medical device or IVD manufacturer wants to receive a Form 483 and/or Warning Letter from the US Food and Drug Administration (FDA). Officially, the FDA Form 483 is referred to as "Notice of Inspectional Observations." The 483 is issued by the FDA field investigator after an on-site inspection and lists deficiencies of your quality system. The observations contained in every Form 483 are based on the inspector's interpretation of the regulations as they relate to your operational GMP quality system.<br/><br/>The field inspector will submit the finalized 483 to his/her superiors and based on the severity of the findings, and a FDA Warning Letter may be issued to your firm.<br/></div>

Barrons

心静自然凉，