DOXPUB 09-0014-SOP

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 Procedures

Included Attachments/Appendices:

Product Recall Action Report - 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