Yakamoz Sirke Ferm Urunleri Gida Tas San Ve Tic Ltd STI Warning Letter Details

Summary

Yakamoz Sirke Ferm Urunleri Gida Tas San Ve Tic Ltd STI, a juice processing facility in Turkey, failed to comply with FDA's Juice Hazard Analysis and Critical Control Point (HACCP) Regulation (21 CFR Part 120) during an inspection conducted from January through February 2022. The facility's HACCP plan for concentrated lemon juice with added ingredients did not include adequate control measures to achieve the required minimum 5-log reduction in the most resistant pathogenic microorganisms likely to occur in the juice over its shelf life. Despite submitting revised HACCP plans in response to FDA's initial findings, the company's documentation remained inadequate to address the violations. The deficiencies rendered the juice products adulterated under the Federal Food, Drug, and Cosmetic Act.