FDA WARNING_LETTER - Misono Food Ltd - October 19, 2015

The FDA inspected Misono Food Ltd's seafood importer establishment from October 14-19, 2015, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123. Specifically, the firm failed to implement an affirmative step to ensure that its refrigerated vacuum-packaged dried tuna roe was processed in accordance with 21 CFR 123.12(a)(2)(ii). This deficiency means the product is considered adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The firm's response dated October 29, 2015, was deemed inadequate, as the implemented affirmative steps, foreign processor's flow chart, and declaration of conformity did not provide sufficient assurance of compliance. Misono Food Ltd must respond within fifteen working days, detailing corrective actions, including documentation of corrected HACCP and importer verification records. Failure to correct these violations could lead to refusal of admission, detention without physical examination, product seizure, injunction, and assessment of re-inspection fees under Section 743 of the Act.