5,000 Years Foods, Inc. Warning Letter Details

Summary

5,000 Years Foods, Inc. received a warning for serious violations in their Chicago kimchi manufacturing facility related to Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls requirements under 21 CFR Part 117. FDA inspectors found that ready-to-eat kimchi products were prepared, packed, or held under insanitary conditions and may have become contaminated with filth or rendered injurious to health. The inspection, conducted from June through August 2021, revealed that the company's hazard analysis failed to adequately evaluate known or reasonably foreseeable hazards, representing a failure to comply with Section 418 of the Federal Food, Drug, and Cosmetic Act. This warning followed a previous regulatory meeting with the company in February 2019, indicating an ongoing pattern of non-compliance.