FDA WARNING_LETTER - Han Yang Oriental Food Mfg - November 27, 2013

On November 4-27, 2013, an FDA inspection of a food manufacturing facility at 3819 94th Street SW, Lakewood, Washington, revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). Laboratory analysis of environmental swabs confirmed the presence of Listeria monocytogenes (L. monocytogenes) in six samples from the finished product packing room floor and a metal cart used for in-process product, indicating inadequate sanitation and potential direct contamination of ready-to-eat rice cakes and tofu.

The facility's ready-to-eat products were deemed adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Additional CGMP violations included: 1. Failure to protect work-in-process from contamination (21 CFR 110.80(b)(5)), with employees handling non-food contact surfaces and then ready-to-eat products/food contact surfaces without handwashing/glove changes. 2. Improper handling and maintenance of equipment (21 CFR 110.80(b)(7)), such as placing clean tofu press trays on a wet floor. 3. Failure to prevent contamination from production procedures (21 CFR 110.80), including an employee returning to the packing room without cleaning footwear after exiting the building. 4.