概述:描述了一个程序，以确保在需要召回产品时，及时有效地检索在欧洲销售的产品。旨在确保在必要时以正确的方式将召回通知相关主管部门。涵盖初始行动、客户通知、产品实际退货、完成和实施。包括符合MDD 94/42/EEC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附件/附录: 产品召回行动报告、目录、咨询通知、目录关于本文件:这不是一个通用模板，它是一个5页的程序，实际上是在FDA监管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，哪些公司会从中受益: 监管事务经理质量保证经理生产经理

Summary:Describes a procedure for ensuring a timely and effective retrieval of products distributed in Europe if the need for product recall arises. Intended to assure that the recall is notified in a correct way to the appropriate Competent Authorities if required. Covers inital action, customer notification, physical return of products, completion and coumentation. Includes provisions for compliance with MDD 94/42/EEC.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 Contents, Advisory Notice, 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