FDA WARNING_LETTER - 5,000 Years Foods, Inc. - August 03, 2021

The FDA inspected a kimchi operation from June 14 to August 3, 2021, as a follow-up to a 2019 Regulatory Meeting, identifying serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). The firm's ready-to-eat kimchi products were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions. Key violations included a failure to adequately evaluate known or foreseeable hazards requiring preventive controls, specifically environmental pathogens like Listeria monocytogenes (confirmed by 5 positive environmental swabs, including near food-contact surfaces), allergen cross-contact, undeclared allergens due to incorrect labeling, and bacterial pathogens in ingredients requiring supply-chain controls. The firm's responses regarding sanitation, environmental monitoring, and corrective actions were found inadequate, lacking a proper recall plan and validation for pathogen destruction. Additionally, CGMP violations included failure to exclude pests (open doors, flies), ensure proper handwashing and glove hygiene, minimize contamination potential (food falling on floor, hoses in standing water, unaddressed sponge use), and use appropriately designed equipment (non-food-grade paint on food-contact surfaces). The FDA requires prompt corrective actions, a written response within 15 working days detailing steps taken to prevent recurrence, and supporting documentation, warning of potential legal action including seizure or injunction if compliance is not achieved.