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 Procedures

Included Attachments/Appendices:

Product Recall Action Report ,Table of Contents, Advisory Notice, Table of Contents

About 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 project
• Compare the quality of your documents against your industry peers
• Learn what other companies in your industry are actually doing

Who Will Benefit:

• Regulatory Affairs Managers
• Quality Assurance Managers
• Manufacturing Managers