Summary of Inspectional Findings

Summary of Inspectional Findings Food Allergen Partnership1999 - 2000 Theresa C. Dziuk Minneapolis District FDA August 13, 2001

Minnesota 41 Inspections Planned 40 Inspections done (1 bakery firm OOB) 31 Bakery 3 Ice Cream 6 Candy Wisconsin 45 Inspections Planned & conducted 23 bakery 10 ice cream 12 candy Food Allergen Partnership Establishments Inspected

Establishment SizeBased on Annual Gross Sales • Small 1: $ 25,000 - $ 49,999 2: $ 50,000 - $ 99,999 3: $100,000 - $499,999 • Medium 4: $500,000 - $999,999 5: $1,000,000 - $4,999,999 6: $5,000,000 - $9,999,999 • Large 7: $10,000,000 - $24,999,999 8: $25,000,000 - $49,999,999 9: $50,000,000 and over

Food Allergen Partnership Key Inspection Focus Areas • Raw Ingredients & Formulations • Compared ingredients with labels • Processing & Production Schedules • Observed potential for cross-contact • Sanitation • Observed cleaning “allergen clean” • Observed rework procedures • Employee Practices & Education • Packaging & Labeling • Obtained labels • Recall procedures & Obtained samples

Food Allergen Partnership Inspectional Findings

Food Allergen PartnershipFirms Inspected that Verified Labels by Commodity

Food Allergen Partnership Inspectional Findings - Label Verification 45 Firms felt that they had adequate procedures to verify label accuracy; However, 15% had incorrect finished product labels. Of the firms that did not verify label accuracy; 51% had incorrect finished product labels.

Inspectional Findings Advisory Labeling

Food Allergen Partnership Firms Inspected that Utilize Rework by Commodity

Food Allergen Partnership Summary of Findings - Rework Of the firms that utilized rework, 48 % of had product that tested positive for undeclared allergen residues.

Food Allergen Partnership Procedures to Prevent Cross-Contact by Commodity

Food Allergen Partnership Summary of Findings – Cross-Contact • Scheduling • “First-in / First-out” • Product Color • Non-dedicated equipment • Inadequately cleaning • Water only • Reused without cleaning

Food Allergen Partnership Sampling & Analysis

Food Allergen Partnership 118 Partnership Samples 73 Samples for peanut protein 40 bakeries, 10 ice cream, 23 candy 45 Samples for egg protein 34 bakeries, 6 ice cream, 5 candy

Food Allergen PartnershipAnalytical Findings - Peanut Sample Results

Food Allergen Partnership Inspectional Findings - The Total Picture

Food Allergen PartnershipPartnership Workshops -Industry Education • 3 Industry workshops - Fond du Lac & Madison, WI - Minneapolis, MN • Presentations on subject from many angles - Local partners - Physicians - Industry representatives - Lawyers - CFSAN - National expert • Distribution of allergen educational materials

Food Allergen Partnership Follow-up Activities

Food Allergen Partnership Follow-up Inspection & Samples

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