概述:描述了在需要产品召回时，确保及时有效地将产品从美国市场移除的程序。旨在确保制定并实施纠正措施计划，以防止未来因同一问题而采取产品召回行动。包括通知、确定纠正措施、实施召回措施、完成和记录。包括符合21 CFR第7.40至7.59部分的规定。包括的章节:目的、范围、责任、参考和适用文件、材料和设备、健康和安全注意事项、文件要求和程序包括的附件/附录:产品召回行动报告-本文件的目录: 这不是一个通用模板，它是一个5页的程序，实际上是在一个受FDA监管的机构的监管事务运作中创建和使用的。公司特定信息（名称、地址、一些图片、专有产品信息等）已被编辑，但内容和格式已基本保留。购买理由:将其作为你自己文档项目的起点，将你文档的质量与你所在行业的同行进行比较，了解你所在行业的其他公司在做什么，谁会从中受益:监管事务经理质量保证经理制造经理

Summary:Describes the procedure for assuring a timely and effective removal of product from the US market if a need for a product recall arises. Intended to assure that a corrective action plan will be developed and implemented to prevent future product recall action due to the same problem. Covers notification, determination of corrective action, implementing a recall action, completion and documentation. Includes provisions for compliance with 21 CFR Parts 7.40 to 7.59.Included Sections:Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and ProceduresIncluded Attachments/Appendices:Product Recall Action Report - Table of ContentsAbout This Document:This is not a generic template, it's a 5-page procedure that was actually created and used in the Regulatory Affairs operations of a FDA-regulated establishment. The company-specific information (names, addresses, some images, proprietary product information, etc.) has been redacted but the content and format have been largely preserved.Reasons to Buy:Use it as a starting point for your own documentation projectCompare the quality of your documents against your industry peersLearn what other companies in your industry are actually doingWho Will Benefit:Regulatory Affairs ManagersQuality Assurance ManagersManufacturing Managers