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Allergen Control Program Verification Checklist
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Verify allergen management from receiving through labeling, including the nine major U.S. allergens and validated changeover cleaning.
FALCPAFASTER Act21 CFR 117
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Allergen Program & Assessment
- Is a written allergen control plan maintained as a preventive control where required? *
- Are all nine major allergens (milk, egg, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, sesame) identified? *
- Is an allergen map/matrix maintained showing allergens by product and line? *
- Are incoming ingredient allergen statements verified against specifications? *
Storage & Segregation
- Are allergen-containing materials stored to prevent cross-contact (segregated or sealed/below)? *
- Are allergen ingredients clearly identified/color-coded in storage and staging? *
- Are dedicated or controlled utensils and scoops used for allergen ingredients? *
Production Scheduling & Cross-Contact Control
- Is production scheduled to run non-allergen or fewer-allergen products first where feasible? *
- Is rework containing allergens controlled to like-into-like products only? *
- Are shared equipment changeovers governed by documented procedures? *
Validated Cleaning & Verification
- Is allergen changeover cleaning validated (e.g., ATP + allergen-specific test kit)? *
- Is post-cleaning allergen verification testing performed and recorded before next run? *
- Allergen swab test result (ppm or negative)
Labeling & Declaration
- Are all allergens declared on finished-product labels in the Contains statement or ingredient list? *
- Is a label reconciliation/verification performed at start-up and changeover to prevent misbranding? *
- Are label changes controlled and obsolete labels destroyed? *
- Are employees trained on allergen awareness at defined frequency? *
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