Christopher Fanelli回答：

Field alert reports, other adverse event reports, these are the types of things that FDA has been, and will continue to use artificial intelligence tools to analyze, because these are things that are objective, and are things that allow for kind of broad data analysis, so for identifying trends, identifying particular concerns, these are the types of things that could trigger a surprise inspection.

现场警示报告（FAR），其他不良事件报告，这些是FDA一直以来就在用,并将继续使用人工智能工具进行分析的内容，因为这些是客观的内容， 并且可以进行广泛的数据分析，因此可以用于识别趋势、识别特定问题，这些情况可能会触发飞检。

FDA has set out a criteria for, FDA will continue to use their risk ranking tool. They had a risk ranking tool pre-COVID, they honed it during COVID, and they have since refined it even further, and claim to be using artificial intelligence to analyze sites for high risk, kind of medium risk and low risk.

FDA已经制定了相关标准，FDA将继续使用其风险排序工具。他们在COVID之前就有一个风险排序工具，在COVID期间对其进行了优化，此后进一步完善，并声称正在使用人工智能对场地进行高风险、中风险和低风险的分类分析。

So, a site that is submitting a lot of field alert reports, would potentially increase their level of risk in FDA's risk analysis tool.

因此，一个提交大量FAR的场地, 其风险等级在FDA的风险分析工具中可能会提高。

Other factors like how much products do they send to the US market?Is it a sterile site or a non-sterile site?If it's a sterile site,what type of sterile product are they manufacturing? These are all kind of factors that FDA evaluates as part of their risk analysis, to determine who's at the top of the list for a surprise inspection.

其他因素，比如他们向美国市场输送多少产品？是无菌场地还是非无菌场地？如果是无菌场地，他们正在生产哪种类型的无菌产品？这些都是FDA在风险分析中评估的因素，以确定谁在飞检名单的首位。

And basically on the output of that, the output of that is sites that are higher risk, are at increased risk for surprise inspections.

而基本上，分析的结果是，风险较高的场地, 面临飞检的风险也更高。

And so, I understand the incentive, companies, US and otherwise, are sometimes hesitant to file field alert reports, because they think it will trigger an inspection.

因此，我理解企业（无论是美国企业还是其他国家企业）有时会犹豫是否要提交FAR，因为他们认为这会触发检查。

And then in some cases, they're right. If there is a significant field alert report that gets submitted with, for example, major sterility assurance concerns or major data integrity concerns, that could potentially trigger an FDA inspection, but you have to be inspection ready regardless.

而某些情况下，他们是对的。如果提交了一份重大FAR，例如，涉及主要的无菌保证问题或主要的数据可靠性问题，这可能会触发FDA检查，但无论如何，都必须做好接受检查的准备。

And if during a routine inspection,FDA observes that a company didn't submit field alert reports when they were required to by the statute, that's a worse outcome than triggering an inspection due to the submission of a field alert report.

如果在例行检查期间，FDA发现企业未按成文法要求提交FAR，这种情况比因提交FAR而触发检查的后果更糟糕。

Those are the types of things that ratchet risk level and compliance risk up for a company. is the failure to submit a field alert report, is a pretty frequently cited warning letter observation, because, right, that's how FDA analyzes risk.

因为这些事情会提高企业的风险等级和合规风险。未提交FAR, 是警告信中相当常见的观察项。因为这就是FDA分析风险的方式。

And if companies are not submitting field alert reports, that's a trust issue. If you're FDA, they can't trust a company that won't submit field alert reports.

如果企业没有提交FAR，那就是一个信任问题。对于FDA来说，他们无法信任一家不提交FAR的企业。