Marukai Foods Co., Inc. (Takasu Factory) – FDA Warning Letter, Feb 20, 2014

The FDA inspected Marukai Foods Co., Inc. in Japan from February 19-20, 2014, to assess compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and 21 CFR Part 101. The inspection found that their Small Young Sardine (4.23 oz. and 8.82 oz.) and Dried Sardine (5 oz.) products are misbranded.

Specifically, the products are misbranded under Section 403(b) [21 U.S.C. § 343(b)] because they are labeled as "sardine" but are actually "anchovies." They are also misbranded under Section 403(f) [21 U.S.C. § 343(f)] as they contain information in two languages (Japanese and English) but fail to repeat all required label information, such as Nutrition Facts, in both languages, violating 21 CFR 101.15(c)(2).

Furthermore, the products are misbranded under Section 403(q) [21 U.S.C. § 343(q)] due to improper nutrition facts formatting. Violations include serving sizes not expressed as "an amount customarily consumed" appropriate to the food (21 CFR 101.12), with the Reference Amount Customarily Consumed