The intent of this webpage is to provide the U.S. Food and Drug Administration (FDA) divisions and state regulatory agencies with the tools and resources to replicate the PFP’s Recall Integration Partnership Project (RIPP) on their own.
Project Goal
The RIPP is an initiative allowing for the development and maintenance of FDA/state stakeholder relationships during recall events. The overarching goal of the project is to encourage enhanced communication and foster an increased understanding of FDA/state roles and responsibilities during recall events to leverage appropriate regulatory or enforcement capabilities to protect public health.
Outcome Statement
This document provides summary information about the outcomes of the innovative Recall Integration Partnership Pilot (RIPP) project implemented by the Partnership for Food Protection’s Surveillance, Response and Post-Response (PFP SRPR) workgroup in 2022. The project was implemented by U.S. Food and Drug Administration (FDA) Human and Animal Food (HAF) Divisions and their state counterparts for a period of four months. Despite many challenges, the project was successful in meeting the planned objectives and many activities were conducted as a result of the RIPP that improved the understanding, collaboration and communication amongst the partner agencies. Building upon the success of the pilot project, the group is moving forward with several planned initiatives to socialize the RIPP’s framework and encourage duplication by other agencies, enhancing the cohesiveness of the Integrated Food Safety System during food recalls.
Objectives
- Understand the role of federal and state partners with a responsibility for recalls
- Understand expectations of partners when a recall occurs
- Determine best practices for conducting recall audit checks to avoid duplication of efforts
- Identify key contacts and preferred method of communication
- Identify barriers to communication, information sharing or collaboration during recall events and determine possible solutions to overcome any identified barriers
- Identify any needs for additional staff training relating to recall response activities, with a proposed timeline to implement
- Create and maintain a feedback mechanism to promote continuous collaboration
Process and Tools
The FDA division and state agency partner pair should complete these high-level tasks as they work together through the project:
Step 1: Each participating agency should complete the pre-project evaluation to establish a baseline in their knowledge and opinions on the collaboration and communication with their partner agency during recalls. The pre-project self-assessments may be discussed at the first meeting to compare each agency’s perspective. | Download Tool |
Step 2: Schedule regular meetings with partner agency representatives and determine which discussion topics will be covered during the meetings. The attached meeting tips and example agenda may be helpful. | Download Tool |
Step 3: Create/update points of contact for both agencies. | Follow Agency Procedures |
Step 4: Document any successes, gaps/barriers and action items identified during the meetings. | Download Tool |
Step 5: Each agency should complete a post-project evaluation to determine the effectiveness of the project. | Download Tool |
Worksheet: This worksheet may be used to document discussions and decisions made during the meetings. | Download Tool |
References
- Partnership for Food Protection’s Best Practices for Improving FDA and State Communication During Food Recalls
- Recall audit checklist training
- RRT Best Practices Chapter 12: Food Recalls
- FDA Enforcement Report email subscription registration
- FDA Product Recalls, Including Removals and Corrections – Guidance for Industry
- FDA Investigations Operations Manual, Chapter 7 – Recall Activities (2021)
- FDA Regulatory Procedures Manual, Chapter 7 (2021)
- CIFOR Toolkit
FDA Recall Regulations
- 21 CFR Part 7, Enforcement Policy – Subpart C Recalls
- 21 CFR Part 7 Preamble
- 21 CFR Part 806, Medical Devices – Corrections and Removals
- 21 CFR Part 806 Preamble
- 21 CFR Part 810, Medical Devices – Recall Authority
- 21 CFR Part 107, Subpart E, Infant Formula Recalls
- 21 CFR Part 1271.440, Human Cell, Tissues and Cellular and Tissue-Based Products Recall Order