Pt Dua Kelinci – FDA EIR, Aug 23, 2023

An FDA inspection of Pt Dua Kelinci in Pati, Jawa Tengah, Indonesia, was conducted from August 22-23, 2023. This limited scope Preventive Controls inspection, performed under the regulatory framework of 21 CFR 117, identified significant deficiencies in food safety. The company, a manufacturer and exporter of ready-to-eat confectionaries and snack foods, received an FDA Form 483 detailing two main violations.

The primary issues cited were the failure to adequately clean and sanitize utensils and equipment as frequently as necessary to prevent allergen cross-contact and contamination, and not maintaining the plant in a clean, sanitary condition and in adequate repair. Specific observations included visibly dirty equipment, containers, walls, and floors; unsanitary cleaning methods such as washing rags in floor puddles; the use of non-food grade cleaners on food contact surfaces; and insufficient separation of allergens in storage areas. Additionally, the firm lacked a Preventive Controls Qualified Individual (PCQI), employee training in sanitation and allergen control appeared inadequate, and cleaning records did not accurately reflect facility conditions.

Management was informed of these non-compliance issues and cautioned about potential penalties under the U.S. Food, Drug and Cosmetic Act. They committed to implementing corrections and submitting a formal response to the FDA within ten business days.