FDA WARNING_LETTER - California Cereal Products - July 11, 2019

The FDA inspected a dry cereal manufacturing facility in Macon, GA, from July 8-11, 2019, and found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). Consequently, the dry cereal products manufactured are deemed adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Significant violations included a failure to effectively exclude pests, with evidence of live insects throughout the facility (21 CFR § 117.35(c)). The plant's construction allowed condensate to drip onto food contact surfaces and exposed product (21 CFR § 117.20(b)(4)). Equipment and utensils were not adequately maintained to prevent allergen cross-contact and contamination, observed through improper sampling procedures, bucket elevator contact with floor product, and rust in a flavor tank (21 CFR §117.40(a)(1)). Additionally, plant floors were not constructed for adequate cleaning and repair, with broken tiles and standing water in the cook area (21 CFR §117.20(b)(4)). While some corrective actions were initiated during the inspection, a comprehensive written response outlining sustainable measures is still required. The firm must respond within fifteen working days, detailing corrective actions and prevention strategies, or face potential regulatory actions like seizure or injunction, and re-inspection fees.