FDA EIR - Dole Fresh Vegetables - Bessemer City - January 07, 2022

An FDA inspection of Dole Fresh Vegetables Inc. in Bessemer City, NC, occurred from December 15, 2021, to January 7, 2022. This comprehensive review was initiated following a Class 1 recall and a Listeria monocytogenes outbreak linked to the facility's products, under the regulatory framework of Preventive Controls for Human Food (21 CFR Part 117). Inspectors identified several objectionable conditions. Main violations included inadequate sanitation controls, specifically concerning the cleanliness of food-contact surfaces and prevention of cross-contamination, with product discharge chutes noted as not being adequately cleaned. The plant's construction and design were found to impede sanitary operations, evidenced by condensation dripping onto exposed products and food-contact surfaces, and hoses left on the floor. Equipment and utensils also showed damage, such as missing conveyor belt material, cracking, rough welds, and gaps, which hindered proper cleaning and maintenance. Additional observations noted deficiencies in the firm's hazard analysis, which did not identify certain foreseeable hazards like glass, wood, plastic, or Staphylococcus aureus in raw materials, and an insufficient follow-up process for consumer complaints regarding illness and foreign objects. During the inspection, Dole Fresh Vegetables Inc. voluntarily ceased operations, recalled all affected products, and initiated a site-wide deep cleaning. Management committed to responding to the FDA's observations in writing and was reminded of their responsibility to maintain compliance with the Food, Drug, and Cosmetic Act.