FDA WARNING_LETTER - Yakamoz Sirke Ferm Urunleri Gida Tas San Ve Tic Ltd STI - February 02, 2022

The FDA conducted a Foreign Remote Regulatory Assessment (FRRA) of a juice processing facility in Turgutlu, Manisa, Turkey, from January 1 to February 2, 2022. The inspection revealed violations of the Juice Hazard Analysis and Critical Control Point (HACCP) Regulation, 21 CFR Part 120, rendering the juice products adulterated under section 402(a)(4) of the Federal Foods, Drug, and Cosmetic Act.

The primary deficiency identified was that the HACCP plan for "Concentrated Lemon Juice with Added Ingredients" and specifically for Bolio and Bogopo lemon and lime juice, revised on February 17, 2022, does not include control measures to consistently achieve a 5-log reduction in the most resistant microorganism, as required by 21 CFR 120.24(a). The critical limits for acidity and hold time were not supported by validation studies provided, as the minimum acidity was below the study's minimum, and different preservatives (potassium sorbate vs. sodium metabisulfite and sodium benzoate) were used. Additionally, the Bolio, Bogopo, and Leaping Leopard revised HACCP plans lacked validation and verification procedures (e.g., record review, instrument calibration, process establishment source/validation studies).

The FDA acknowledged the firm's responses from February 14 and April 13, 2022,