- A+
Following an FDA inspection, you may be issued an FDA Form 483, a form listing Inspectional Observations of current issues and/or potentially problematic conditions.
在经过FDA检查后，您可能会收到一份FDA表格483，该表格列出了对当前问题和/或潜在问题情况的检查意见。
First and foremost, it’s important to take these observations seriously. Although it does not represent the FDA’s final determination on compliance, deciding not to respond to FDA 483 observations within the 15-business day window will almost certainly result in a Warning Letter or further enforcement action.
首先，认真对待这些发现项是至关重要的。尽管这并不代表FDA对合规性的最终决定，但如果在15个工作日内不对FDA的483表格做出回应，几乎肯定会导致警告信或进一步的执法行动。
While crafting a strong response is crucial, keep in mind it’s just one part of a larger recovery process.
虽然制定强有力的应对措施至关重要，但请记住，这只是更大的整改过程的一部分。
Before we jump into what makes a response effective and compelling, let’s briefly go over proper layout:
在我们开始讨论什么能让一个回应变得有效和引人注目之前，让我们先简要回顾一下正确的报告架构：
3 Parts of an FDA 483 Response
回复FDA的483表的三个部分
The structure of your response should follow this 3-part outline:
回复FDA的483表的三个部分应该包括：
Cover Letter
附信
In this introduction, respectfully thank the FDA for identifying opportunities for continuous improvement and clearly state your obligation to comply with the law through commitment to action. This should be written by senior management.
在本介绍中，恭敬地感谢FDA确定了持续改进的机会，并明确声明您有义务通过承诺采取行动来遵守法律。这个应该是高层写的。
Body
主体
Restate each observation and include the following for each one:
重申每个观察结果，并在每个观察结果中包含以下内容:
1）Background information regarding the observation
发现项的背景信息
2）An assessment of the root cause of the problem or commitment for further investigation if additional time is needed, with target dates for completion
对问题根本原因的评估，或者如果需要额外时间，则承诺进行进一步调查，目标完成日期
3) Corrective actions, immediately corrected if possible with completion dates and objective evidence to be included with attachments or attainable target dates for completion
纠正措施，如有可能，立即纠正，并附上完成日期和客观证据，或可达到的完成目标日期
4）Preventive actions (particularly for any systemic issues found)
预防措施（尤其是针对发现的任何系统性问题）
5）Reference to objective evidence to be included as attachments for each completed action
对客观证据的引用，作为每个已完成行动的附件
6）Commitment to provide a follow-up response, per specific date, if all actions cannot be completed prior to the 15-day submission timeline for the initial response
如果在初始响应的15天提交时间表之前无法完成所有行动，则承诺按具体日期提供后续响应
List of Attachments
附件清单
Clearly describe and identify any attachments you provide. The numbers and names referenced in the body should exactly match the number and name in the list.
清楚地描述和识别您提供的任何附件。正文中引用的数字和名称应该与列表中的数字和名称完全匹配。
Attachments should be easy to find, read and understand. For example, if an SOP is attached, reference the specific section(s) that address the issue in the body to make it easy for the reviewer. Avoid forcing them to search through reams of documentation to understand your improvements.
附件要易于查找、阅读和理解。例如，如果附加了标准操作程序，请参考正文中解决问题的特定部分，以便于审阅者阅读。避免强迫他们搜索大量文档来理解你的改进。
Working with this basic outline, here are 6 essential things to keep in mind when crafting your response:
根据这个基本的大纲，在设计你的回答时，有6件重要的事情要记住:
1. Be clear 要清晰
While the details of your response depend on the particular observations cited, it should specifically respond to each observation, be easy to follow and leave no doubt about what you intend to do to resolve the situation.
虽然你的回答的细节取决于所引用的具体观察结果，但它应该对每个观察结果做出具体的回应，要易于理解，并且不要怀疑你打算做什么来解决这种情况。
2. Be compelling 引人注目
Typically, the most effective way to write your response is in narrative form. State the observation and address it in a clear, chronological format allowing you to put your company in the best light possible.
通常，最有效的回复方式是以叙述的形式。陈述你的观察结果，并以清晰、按时间顺序排列的格式来表达，让你尽可能地把你的公司放在最好的位置。
3. Anticipate potential questions 预测潜在的问题
Your response should first focus on addressing the central issues raised in the observations and provide accurate, objective evidence that anticipates and answers the potential questions your action plan lays out.
您的回应应首先集中于解决观察中提出的核心问题，并提供准确、客观的证据，预测和回答您的行动计划中提出的潜在问题。
4. Carefully manage disputes 小心处理纠纷
If you decide to dispute an observation, you must be prepared to back it up with enough factual, objective evidence to be convincing.
如果你决定对一个观察结果提出异议，你必须准备好用足够的事实、客观证据来支持它，以使其具有说服力。
Never ignore an investigator’s claims. Even if you believe something may be inaccurate, your response should clearly provide enough explanation required to show exactly why you do not concur with the observation.
永远不要忽视调查员的声明。即使你认为某件事可能是不准确的，你的回答也应该清楚地提供足够的解释来说明你为什么不同意这个观察。
4. Support all claims with facts and hard data 用事实和确凿的数据支持所有的主张
Every claim and response you make in your response must be backed up with objective evidence.
你在回复中提出的每一个要求和回答都必须有客观的证据支持。
Unsupported or poorly explained assertions are of no value to the FDA and only raise more doubts about your ability to resolve the problems identified.
不受支持或解释不当的主张对FDA没有价值，只会让你对解决已发现问题的能力产生更多怀疑。
5. Assess your response for quality and thoroughness.
评估您的回复的质量和彻底性
Proofread, edit and re-work your response before submission to ensure it is as complete and compelling as possible. Even one typo or inaccurate statement can reduce the FDA’s confidence in your ability to provide high quality products to the market and protect the public, increasing the likelihood that a Warning Letter will be issued and potential escalation to enforcement action.
提交之前，对您的回复进行校对、编辑和修改，以确保它尽可能完整和引人注目。即使是一个拼写错误或不准确的陈述也会降低FDA对您向市场提供高质量产品和保护公众的能力的信心，增加发出警告信的可能性，并可能升级到执法行动。
To ensure perfection and objectivity you may choose to seek the help of third party experts to conduct an independent assessment of the thoroughness and acceptability of the response prior to submission.
为了确保完美和客观，您可以选择寻求第三方专家的帮助，在提交之前对响应的彻底性和可接受性进行独立评估。
