以实际经验来看，是会有fda派出年轻检察员与成熟检察员搭配的情况。相对来说年轻检察员的审计风格不会像一些传说中的审计杀手那么的具有挑战性。但这个毕竟只是个例。

Michael Varrone回答:

This is a good question because there could potentially be a lot of young auditors, with the recent workforce reductions at the Food and Drug Administration.

这是一个很好的问题，因为FDA最近裁员，可能会引入许多年轻的审计员检查员。

And by the way, it remains to be seen, how those workforce reductions will affect the inspections, and as far as their frequency and scrutiny going forward. It appears that the agency has not eliminated any inspector positions.

顺便说一下，这些裁员将如何影响检查, 以及未来检查的频次和审查力度，还有待观察。目前看来，FDA并没有裁减任何检查员的职位。

Now, there has been some discussion about support staff, who help the inspectors to, for example, arrange their travel to certain jurisdictions, and without their help, there's not a lot of assistance for those inspectors.

不过，确实有一些关于支持人员的讨论，这些支持人员帮助检查员安排前往某些辖区的行程，如果没有他们的帮助，检查员就得不到太多的支持。

Now, FDA may have since hired those people back, but going forward, there's going to be a priority, as we said, on inspections and foreign inspections in particular. So I expect the agency to do what it can to get those inspectors out.

现在，FDA可能已经把这些人招回来了, 但未来，正如我们所说，检查，特别是国外检查，将成为优先事项。所以我预计FDA会尽其所能把这些检查员派出去。

Now, there have been a lot of experienced inspectors who have left. And that means a lot of younger auditors and investigators at FDA.

现在，确实有许多经验丰富的检查员已经离职了。这意味着FDA有很多更年轻的审计员和检查员。

but it could lead to less scrutiny in some instances, for data integrity inspections in particular, for individuals who are not particularly experienced in data integrity inspections, they may not know what to look for. And so they may not actually scrutinize in detail as much as an experienced inspector would.

但这可能会导致在某些情况下审查不那么严格，特别是在数据可靠性检查方面，对于那些在数据可靠性检查方面经验不足的检查员来说，他们可能不知道该关注什么。因此，他们可能不会像经验丰富的检查员那样详细审查。

On the flip side, because they don't have the experience, and have not seen as many companies and processes, they may be more strictly by the book on how they do things, and engage in observations and cite companies for things that a more experienced auditor may not necessarily cite the company for. So I think in ways they could be more lenient, or in other ways they could be more strict.

另一方面，由于他们缺乏经验，也没有见过那么多公司和流程，他们可能会更严格地按照规定行事，并且会因为一些更有经验的审计员不一定会指出的问题，而签发观察项。所以我认为在某些方面他们可能会更宽松，而在其他方面他们可能会更严格。

It frankly just depends because when you're dealing with a less experienced inspector, you don't have a good history on them to know how they operate.

坦率地说，这完全取决于具体情况，因为当你面对一个经验不足的检查员时，你无法通过其过往记录来了解其工作方式。

Christopher Fanelli回答：

And certainly one of the things that I've seen is,firstly, to Mike's point, investigators being very by the book, which is to say they don't engage in a lot of collaboration or discussions with companies during inspections.

当然，我看到的情况之一是，首先，就像Mike说的，检查员非常严格地按照规定行事，也就是说，他们在检查期间不怎么与公司进行合作或讨论。

They come in, they do their inspection day and they leave. In many cases, they don't have a closeout. They don't really engage in conversation with the team at the companies is one thing I'm seeing.

他们来了，完成检查，然后就离开。很多情况下，他们不开结束会议。他们并没有真正与公司团队进行交流，这是我看到的一个现象。

And another thing, as a result, there's actually often a lot of confusion in the 483s that get issued, which to my perspective makes the 483 response even that much more important.

另一个现象是，由于这种情况，在签发的483表中，常常有很多令人困惑的地方，从我的角度来看，这使得对483表的回复变得更加重要。

Because investigators that sometimes make mistakes, or don't have all of the information when they write their observations, the 483 response is going to be the primary opportunity or the primary avenue, for making those corrections, making those clarifications, and for pushing back on the observations, and highlighting that, well, no, it's not right.

因为检查员有时会犯错误，或者在写观察项时没有掌握全部信息，对483表的回复将成为进行更正澄清以及提出异议的主要机会或主要途径，并强调说，不，这不正确。

There are additional information and additional context needed, to understand the state of control. And so, as a result of there being more young auditors, the 483 response is becoming more and more important.

需要额外的信息和额外的背景, 来理解受控状态。因此，由于有更多年轻的审计员，对483表的回复变得越来越重要。