TSUKIJI MOTOHIKO CO., LTD.

WARNING LETTER TSUKIJI MOTOHIKO CO., LTD. MARCS-CMS 578659 — May 07, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Express Delivery Product: Food & Beverages Recipient: Recipient Name Mr. Ito Motoki Recipient Title President TSUKIJI MOTOHIKO CO., LTD. 1 Chome 12-12 Minamisuna Koto , Tokyo Japan Issuing Office: Center for Food Safety and Applied Nutrition 5001 Campus Drive College Park , MD 20740-3835 United States WARNING LETTER MAY 7, 2019 VIA EXPRESS DELIVERY Mr. Ito Motoki, President Tsukiji Motohiko Co., Ltd. 1 Chome 12-12 Minamisuna Kato, Tokyo Japan Reference #578659 Dear Mr. Motoki: The U.S. Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Tsukiji Motohiko Co., Ltd., Kato-Ku, Tokyo, Japan, on February 21 & 22, 2019. During that inspection, we found that you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). At the conclusion of the inspection, the FDA investigator issued an FDA-483, lnspectional Observations, listing the observations made at your firm. We acknowledge receipt of your responses sent via email on March 7, 2019 and April 1, 2019. However, our evaluation of your response revealed it was not adequate, as further described in this letter. In accordance with 21 CFR 123, failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish and fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your frozen, vacuum packaged herring and salmon seaweed and threaded herring products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the 4th Edition of the Fish and Fisheries Products Hazards and Control Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov. Your significant deviation is as follows: You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine where there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for frozen, vacuum packaged salmon wrapped seaweed; frozen, vacuum packaged herring wrapped seaweed; and frozen, vacuum packaged threaded herring, to control the food safety hazards of undeclared allergens and Clostridium botulinum growth and toxin formation. The HACCP plan should include handling instructions to control Clostridium botulinum growth and toxin formation, such as labels with a statement "Keep Frozen, Thaw under refrigeration immediately before use." The HACCP plan should also ensure that allergens, such as soy are accurately identified on the product labels you apply to these products. We acknowledge receipt of your March 7, 2019 and April 1, 2019, responses, however your responses did not include a HACCP plan to control the hazards that are reasonably likely to occur for your products. You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. More specifically, your response should include documentation and information that would assist us in evaluating your corrections, including your revised HACCP plan and five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of 5 production date codes of products) to demonstrate implementation of the plan, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the seafood HACCP regulation. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations. If you believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration. If you do not respond to this letter or if we find your response inadequate, we may take further action. For instance, we may take action to refuse admission of your fish and fishery products under section 801(a) of the Act (21 U.S.C. §381(a)) including placing them on detention without physical examination (DWPE). FDA's DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA's Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation is Import Alert #16-120. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.html This letter may not list all the deviations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable regulations, including the seafood HACCP regulation (21 CFR 123), and the current Good Manufacturing Practices regulation (21 CFR 117 Subpart B). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. Additionally, Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. § 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs. Please consider providing a copy of this letter to your U.S. Agent. Please send your reply to the Food and Drug Administration, Attention: Rosemary Sexton, Compliance Officer, Office of Compliance, Division of Enforcement, Food Assessment and Adulteration Branch (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Rosemary Sexton via email at rosemary.sexton@fda.hhs.gov. Please reference case #578659 on any submissions and within the subject line of any emails to us. Sincerely, /S/ William A. Correll, Jr. Director Office of Compliance Center for Food Safety and Applied Nutrition Content current as of: 07/16/2019 Regulated Product(s) Food & Beverages