Description
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
Product Details
- Edition:
- 2
- Published:
- 08/01/2007
- Number of Pages:
- 5
- File Size:
- 1 file , 330 KB
