Quick Foods Co. – FDA Warning Letter, Jul 19, 2017

On September 13, 2017, the FDA issued a Warning Letter to Quick Foods Co. following an inspection from July 6-19, 2017. The inspection revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practices (CGMP) regulations (21 CFR Part 110).

The FDA found that Quick Foods Co.'s ready-to-eat tuna salad, turkey swiss, corn beef swiss, chicken and cheese, ham and cheese, and Italian sandwiches were adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, having been prepared, packed, or held under insanitary conditions.

Specific violations included: 1. **HACCP Plan Deficiencies:** The tuna salad sandwich HACCP plan failed to list scombrotoxin (histamine) formation and pathogen growth/toxin formation as reasonably likely food safety hazards, as required by 21 CFR 123.6(a) and (c)(1). 2. **Employee Hygiene:** Employees were observed touching ready-to-eat sandwiches after handling contaminated labels, cooler doors, light switches, and scratching themselves without washing hands, violating 21 CFR 110.10(b)(3). 3. **Eating in Production Areas:** An employee