FDA WARNING_LETTER - Marumi - July 17, 2014

The FDA inspected Marumi Co., Ltd.'s facility in Veliki Zdenci, Croatia, from July 16-17, 2014, to assess compliance with the Federal Food, Drug, and Cosmetic Act. The inspection revealed that Marumi's dumpling wrapper products (Frozen Shumai Skin, Frozen Wonton Pi Shell, Frozen Wontan Skin, Gyoza Skin, and Shumai Skin) are misbranded under 21 CFR Part 101.

Violations include: 1. **Misbranding under Section 403(q) (Nutrition Facts):** * Serving sizes are not based on the appropriate 60g Reference Amount Customarily Consumed (RACC) for wrappers, leading to incorrect nutritional information. * Gyoza Skin and Shumai Skin labels fail to declare saturated fat. * Frozen Shaumai Skin and Frozen Wontan Skin have incorrect % Daily Value declarations for calcium and iron. * Gyoza Skin label fails to declare calories to the nearest 5-calorie increment.

2. **Misbranding under Section 403(i)(2) (Ingredient Declaration):** * Failure to declare "sucrose esters of fatty acids" by common name on Gyoza Skin and Frozen Shumai Skin. * Incorrect declaration of "sorbit" instead of "sorbitol" on Gyo