Pt Dua Kelinci

Warning LetterOpen

Hadi Sutisno President/Director Pt Dua Kelinci Jalan Raya Pati Kudus Km 6.3 Pati Kudus Pati, Jawa Tengah 59163 IndonesiaFEI 3009598071Issued Feb 9, 2024Center for Food Safety and Applied Nutrition

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3009598071.

Letter Details

Firm: Pt Dua Kelinci
Location: Hadi Sutisno President/Director Pt Dua Kelinci Jalan Raya Pati Kudus Km 6.3 Pati Kudus Pati, Jawa Tengah 59163 Indonesia
FEI Number: 3009598071
Country: United States
Issue Date: February 09, 2024
Issuing Office: Center for Food Safety and Applied Nutrition
Product Type: Food & Beverages
Status: Open

Summary

PT Dua Kelinci, an Indonesian manufacturer of ready-to-eat confectioneries and snack foods, was cited for serious violations of Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls regulations under 21 CFR Part 117. During an August 2023 inspection, FDA investigators found that the company failed to maintain clean and sanitary plant conditions, including washing production utensils and equipment in visibly dirty water without proper sanitization, which resulted in RTE food products being deemed adulterated and potentially contaminated with filth or injurious to health. The company submitted a response in September 2023 describing corrective actions, but FDA determined the violations were serious enough to warrant formal enforcement action.