Managing Recall and Traceability Are You Ready? TGCon/Final...– Documented recall policy and procedures • Voluntary recall decision, notify FDA regional coordinator, & submit required

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Managing Traceability and Recalls: Are You Prepared?

Presented for TGCon 2019

Presented for TGCon 2019April 25, 2019

Learning Objectives• Key terms/definitions

– Office of Inspector General report• Guidance documents for Industry & FDA Staff• 21 CFR Part 7, Subpart C

– Policy, procedures, and industry responsibilities– Required FDA interaction/progress reporting

• Risk mitigation strategies– Identify traceability concerns– Prepare recall strategy for most likely event

• Defined responsibilities for accurate reporting– Confirm readiness using internal audits & mock exercises


Key Terms/Definitions

• Responsible Individual- Positions of power/authority to detect, prevent, or correct FDA violations

• Recall- Firm's removal/correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure– Recall does not include a market withdrawal or a stock recovery

• Recall strategy- Planned specific course of action to be taken in conducting a recall, which addresses the depth of recall, need for public warnings, and extent of effectiveness checks for the recall


Office of Inspector General Report 2017

• Conclusion: FDA food recall process did not always ensure safety of the nation’s food supply:

• That recalls were initiated promptly by the firm• Incomplete/inaccurate consignee information from firm initiating the

recall • FDA recall procedures for effectiveness not followed

– Status reports/decision making not complete• FDA initiated Strategic Coordinated Oversight of Recall Execution

(SCORE), new QS procedures & timelines.


Why Recalls are so Important

FDA Recalls (Class 1 & 2)

5th Annual FDA Reportable Foods Registry (May 2016)


Discussion

• Have you experienced a recall or voluntary product removal?

• Do mock exercises cover all aspects for recalling product?

• What was effective, not effective, and how do you know?


FDA Guidance Documents*

• Draft, “Lists of Retail Consignees to Effectuate…Recalls” (Sept. 2018)– Work with firm for accurate public notification– Identify retail outlets for “Severe Adverse Health Consequences or

Death to Humans or Animals” (SAHCODHA)• Applicable to class 1, some class 2, or recalls not yet classified• Help public identify unsafe food not easily identified, i.e. no

picture, lot code, UPC #, bar code, etc.

* Does not apply to USDA regulated products


FDA Guidance Documents• Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C;

Guidance for Industry and FDA Staff • (Feb. 2019)

– Recall means “violative product”– Public Warning by firm, FDA, or both

• Urgent circumstance (widely distributed product, internet sales, etc.) done on a case-by-case basis

• A SAHCODHA hazard• FDA usually reviews firm’s “recall strategy” for adequacy but not

required to notify the firm if used


FDA Guidance Documents

• Public Warning Under 21 CFR Part 7, Subpart C continued– Short, accurate, and should not use “abundance of caution” if illness

or pathogens are found– Other languages may be needed– Weekly FDA Enforcement Report with updates

• More guidance documents – Reportable Food Registry Q&A guidance, etc.

Disclaimer: “if you wish to use an alternative approach…contact the FDA”


21 CFR Part 7, Subpart C• Company responsibilities for firm initiated recall

– Documented recall policy and procedures• Voluntary recall decision, notify FDA regional coordinator, & submit required

information– Submit firm’s recall strategy

• Results of health hazard evaluation• Ease of product identification• Amount of product in commerce• “Depth” of recall necessary, i.e. wholesale, retail, and consumer• Specific methods for contacting the consignees• Effectiveness checks shared with FDA

– Actions taken for “non-responders”.


21 CFR Part 7, Subpart C• FDA responsibilities

– Recall classification• Likelihood/Severity, susceptible consumers, etc.

– Review firm’s recall strategy• Public warning warranted?• Effectiveness checks, i.e. “depth” of recall

–Percent contacted (Level A-E)• Review firm’s root cause investigation to determine if on-site visit

is necessary


21 CFR Part 7, Subpart C

• FDA guidance to minimize “disruptive” effects of recalls– Prepare and maintain contingency

plans for initiation and completing a recall

– Proper product coding to identify violative products

– Maintain accurate and up to date records for product distribution


Discussion

• Who is responsible for obtaining/reviewing guidance documents?• Do we have a draft recall strategy?• Do we have the FDA recommended templates?• Do all departments understand the importance of accurate

information?• Do internal audits & mock exercises confirm effectiveness?


Risk Mitigation Strategies• Accurate traceability data is critically important

– Manufacturing• All raw materials

–Bulk systems-”clean break”• Rework if applicable• Packaging materials (labeling)

– Distribution• Warehouse, wholesaler, retail, and customer• Accurate contacts


Risk Mitigation Strategies

• Prepare a draft recall strategy– Most likely recall for your commodity per the RFR– Develop recall strategy in advance

• Analyze your distribution chain and retail sales such as big box stores, large retailers, restaurants, convenience stores, internet sales, etc.

–Determine “depth” of recall• Product description & pictures


Mock Exercises• Conduct two to four times per year

– At least one after hours or weekend test • Unannounced would be best

– Trace forward and backwards• Entire Recall Team should participate

– Use a scenario that involves communication with the media and verifying retail contacts with sales

• A designated observer should take notes• Gap identification, debrief, and follow-up


Summary Recall/Traceability

• Guidance documents and updates to regulations are important• Policy/procedures must address requirements in the CFR

– Personnel must be trained and capable• Traceability data for raw materials and distribution contact information

must be accurate– Internal audits confirms accuracy of records/data

• Mock exercises will confirm competency


Winston Churchill

“If you fail to plan, you plan to fail.”

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