Food Safety expert breaks down the expectations outlined in FDA’s “Recall Ready” guidance, what challenges are often encountered when executing a product recall, and what industry best practices are for preparing to successfully navigate a product recall.

1. FSMA Fridays Webinar Series
Monthly Industry News, Updates & Trends for Food, Beverage, & CPG Manufacturers
FDA Expectations:
How to Become “Recall Ready”
Mary Hoffman
Food Safety Director
The Acheson Group - TAG

2. Monthly Industry Update:
✔FSMA Related News
✔Regulation Changes & Updates
✔Industry Trends
✔Q&A with TAG
What is FSMA Fridays?
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3. ✔Only panelist microphones are on
✔Ask questions! (Q&A at end)
✔Recording link will be shared
✔Audio issues: use call-in number
Watch prior FSMA Friday recordings at
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Before We Get Started…
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4. Meet Your FSMA Friday Speaker
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Jim Albright
FSMA Friday Host
Mary Hoffman
Food Safety Director
Mary has over 20 years of technical and leadership
experience at a variety of food production companies,
directing corporate and facility-level quality, R&D, and
laboratory teams and maintaining complete oversight of
food safety management systems.
She specializes in developing proactive initiatives to
assure the safe manufacture of food - including supply
chain risk mitigation, allergen control, environmental
controls and monitoring, microbiological testing, and
behavior-based Good Manufacturing Practice (GMP)
coaching programs.
CERTIFIED
PRACTITIONER

5. FSMA FRIDAYS
Regulatory Updates
● Proposed Rule: Food Labeling-Nutrient Content Claims;
Definition of the Term Healthy
● FDA Release: Overview of Efforts to Improve the Safety of Imported Produce
● FDA Release: Food Safety Prevention Strategies
Mary Hoffman
Food Safety Director

6. FSMA FRIDAYS
• Review the FDA Guidance Document for Voluntary Recalls
Session Overview
• Discuss insights, challenges, and industry best-practices
FSMA FRIDAYS
FDA Expectations:
How to Become “Recall Ready”
Mary Hoffman
Food Safety Director

7. FSMA FRIDAYS
“Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C:
Guidance for Industry and FDA Staff”
Industry Recommendations
● Recall initiation procedures
● Identification of and response to product issues
● Recall communications
FDA assistance with carrying out product recall responsibilities
● Recall initiation procedures

8. FSMA FRIDAYS
General Preparations
Identify appropriate personnel
● Recall team
● Assign responsibilities
● Identify alternate personnel (backups)
Train personnel on their responsibilities
● Understanding of their role
● Mock recalls
● Metrics to identify recall plan opportunities

9. FSMA FRIDAYS
General Preparations (Continued)
Recall communication plan
● Internal
● FDA / Regulatory
● Direct accounts
Communication templates
● Notification letters
● Press releases
● The public
FDA encourages the use of
electronic communications
for conveying voluntary
recall communications.
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10. FSMA FRIDAYS
General Preparations (Continued)
Reporting requirements
● Reportable Food Registry
● Adverse event support for dietary supplements
● Infant formula reporting requirements
Product coding / Lot identification (or batch, unit, etc.)
● Define and limit the scope of a recall
● Allow consignees to separate violative lots from unaffected lots
● Allow consumers to recognize an affected product

11. FSMA FRIDAYS
General Preparations (Continued)
Maintain Distribution Records
● Location of products being recalled
● Instructions extended to all further steps in the distribution chain
● Record Retention
○ Exceeds the shelf life and expected use of the product

12. FSMA FRIDAYS
Procedures for initiating and Performing a Recall
Assign responsibility and describe to perform all actions:
● Cease distribution and sales of affected product
● Develop a recall strategy
● Notify direct accounts
○ Response instructions
○ Instructions for disposition of recalled product
● Notify the public about a product that presents
a health hazard
Personnel training

13. FSMA FRIDAYS
What to do if you THINK there is a problem
Identify the problem
● Internal report
● Testing result
● Consumer complaints
● Communications from a regulatory authority
● Reports of adverse events
Investigate the problem
● Determine whether a deviation occurred that may have
resulted in a product being adulterated or misbranded
● Ensure potential risks are consistently and adequately assessed

14. FSMA FRIDAYS
What to do if you THINK there is a problem (Continued)
Make decision and take action
● Responsibility for initiating a recall
● Scope of the recall
● Depth of the recall
● Decision to discontinue production
and distribution of product
Consult with the FDA
● FDA Regional Coordinator

15. FSMA FRIDAYS
How to Initiate a Voluntary Recall
● Notify Direct Accounts
● Issue a press release or public notice, if applicable
● Execute your prepared communication plan
● Notify the FDA

16. FSMA FRIDAYS
How the FDA Works with a Recalling Firm
Recall Coordinators are the agency points-of-contact
● Provide information about the recall process
● Work closely with the firm throughout the course of the recall
○ Determine if the action is a recall
○ Develop the recall strategy
○ Review communications
○ Monitor the destruction, reconditioning, or disposition of recalled products
FDA may request that a firm initiate a recall if:
● A product presents a risk of illness or injury or gross consumer deception
● The firm has not initiated a voluntary recall of the product
● Agency action is needed to protect public health

17. FSMA FRIDAYS
Summary
➔ Review your Recall Plan
➔ Test your Recall Plan
➔ Continually Improve your Recall Plan
➔ Remain Recall Ready!
Mary Hoffman
Food Safety Director

18. Q&A
FSMA FRIDAY
Mary Hoffman
Food Safety Director

19. ✔ FSMA Friday Session Recordings & Content Library
Resources & Future Events
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✔ TAG Newsletter
✔ Global Food Safety Consultants: AchesonGroup.com
✔ FSMA Friday LinkedIn Group
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