FDA WARNING_LETTER - Yamahide Shokuhin, Inc. - March 28, 2014

This FDA Warning Letter, Reference No. # 445114, was issued to Yamahide Shokuhin, Inc. following an inspection on March 27-28, 2014, at their facility in Miki-shi, Japan. The letter addresses deviations from the United States Food and Drug Administration’s seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123.

The FDA determined that the firm's dried shaved bonito (dried bonito flakes) are adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under conditions that may render them injurious to health.

Significant deviations include: 1. **Failure to list critical control points (CCPs) in the HACCP plan (21 CFR 123.6(a) and (c)(2)):** * No CCPs for unrefrigerated processing steps to control scombrotoxin (histamine) formation, particularly after rehydration. * No CCPs for controlling pathogenic bacteria growth and toxin formation, including *Staphylococcus aureus*, during unrefrigerated processing and after cooked product contacts un-heat-treated equipment. * No CCPs for container integrity testing during automatic packing to prevent moisture exposure, which could lead to scombrotoxin formation