FDA WARNING_LETTER - Zuccaros Fruit and Produce Company, Inc. - February 04, 2011

The FDA conducted an inspection of Zuccaro’s Produce Company in Minneapolis, Minnesota, on January 31, February 1, and February 4, 2011. The inspection revealed a violation of Title 21 of the Code of Federal Regulations, Part 110 (21 CFR Part 110) – Current Good Manufacturing Practice (CGMP) regulations, rendering their shredded lettuce and frozen food products adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)) due to insanitary conditions. Specifically, the firm failed to construct its plant and facilities to prevent drip or condensate from contaminating food, food-contact surfaces, or packaging materials, as required by 21 CFR 110.20(b)(4). FDA observed condensate accumulating on the ceiling directly above the shredded lettuce rinsing area. The FDA noted that processing fresh produce into fresh-cut products increases contamination risk and recommended purchasing produce grown using Good Agricultural Practices (GAP) and processing lettuce to avoid pathogens, referencing the “Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables, 2008.” Zuccaro’s Produce Company was required to notify the FDA within 15 working days of the steps taken or planned to correct the violation and prevent recurrence, with potential regulatory actions like product seizure or injunction if not addressed promptly.