FDA WARNING_LETTER - Marutoshi Co. Ltd. - March 18, 2014

On March 17-18, 2014, the FDA inspected Marutoshi's seafood processing facility in Kagoshima-shi, Japan, and found violations of the seafood Hazard Analysis Critical Control Point (HACCP) regulation (21 CFR Part 123). The inspection resulted in an FDA 483, Inspectional Observations.

Marutoshi's May 10, 2014, response, including a revised HACCP plan, blank monitoring records, a laboratory report, and a corrective action plan, was deemed inadequate. The FDA determined that Marutoshi's Bonita tuna flake products 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 a critical control point for the (b)(4) of Bonita tuna flakes in the revised HACCP plan to control pathogenic bacteria, as required by 21 CFR 123.6(a) and (c)(2). The FDA recommends a critical control point for storage at 40°F (4.4°C) or less with continuous monitoring. 2. Inadequate corrective action plan for Bonita tuna flakes, failing to ensure the cause of critical limit deviation is corrected at the (b)(4)