- Delivery Method:
- Via Express Delivery
- Food & Beverages
Recipient NameMr. Kazunori Matsuda
- Kakushime Matsuda Suisan
- Issuing Office:
- Center for Food Safety and Applied Nutrition (CFSAN)
5001 Campus Drive
College Park, MD 20740
SEP 18, 2019
Dear Mr. Matsuda:
The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Kakushime Matsuda Suisan, Hakodate, located at 247 Furukawa-Cho, Hakidate, Hokkai-do, Japan on July 8 and 9, 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 response sent via email on July 17, 2019. Your response included a revised hazard analysis and HACCP plan entitled "Control; of Raw Herring Process" dated July 17, 2019 that covers your herring products, and product label for "Herring Split." 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, (b)(4) packaged salted and partially dried 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 deviations are as follows:
1. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6 and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm's revised HACCP plan entitled "Control; of Raw Herring Process," which covers all of your frozen, (b)(4) packaged salted and partially dried herring products, including the herring stuffed with salted herring roe does not list critical control points for controlling the food safety hazards of scombrotoxin (histamine) formation, pathogen growth and Clostridium Botulinum (C. botulinum) in your frozen (b)(4) packaged salted and partially dried scombroid-species fish products. Specifically, your revised HACCP plan does not list a critical control point (CCP) of:
a. Thawing of your frozen fish to control scombrotoxin (histamine) formation. During the inspection our investigator noted that your firm thaws the frozen herring in ambient temperature water ((b)(4)°C ((b)(4)°F)) for approximately (b)(4) hours. FDA recommends that thawing be conducted under refrigeration of 40°F (4.4°C) or below with continuous temperature monitoring with a visual check of the recorded data at least daily.
b. Brining of fish to control scombrotoxin (histamine) formation and roe to control pathogens. During the inspection our investigator noted that your firm brines herring in an ambient production room for approximately (b)(4) hours and herring roe in an ambient production room for approximately (b)(4) hours. FDA recommends that brining be conducted under refrigeration of 40°F (4.4°C) or below with continuous temperature monitoring with a visual check of the recorded data at least daily.
c. Drying of fish to control scombrotoxin (histamine) formation and pathogen growth in roe. During the inspection our investigator noted that your firm partially dries herring stuffed with salted roe in drying chambers at approximately (b)(4)°C ((b)(4)°F) for at least (b)(4) hours. FDA recommends that drying be conducted under refrigeration of 40°F (4.4°C) or below with continuous temperature monitoring with a visual check of the recorded data at least daily.
d. Labeling of frozen (b)(4) packaged fish. During the inspection our investigator noted that your firm's herring products are distributed frozen in (b)(4) packaging. If mishandling, this type of packaging creates an environment which is conducive to C. botulinum growth and toxin formation. Therefore, FDA recommends that your HACCP plan include appropriate controls to ensure each product is appropriately labeled with handling instructions (e.g., "Important, keep frozen until used, thaw under refrigeration immediately before use").
As an alternative to including multiple critical control points for your unrefrigerated processing steps, such as (b)(4) you may consider an "Unrefrigerated Processing" critical control point to control scombrotoxin (histamine) formation and pathogens as a result of time and temperature abuse. An unrefrigerated processing CCP should also include your existing critical control points such as "(b)(4)" and "(b)(4)" - FDA noted that the revised critical limits for these critical control points are inadequate, in that they fail to include adequate time/temperature controls. Once you have included this as a CCP, FDA recommends the following controls for raw, ready-to-eat products:
• If any time the product is held at internal temperatures above 70°F (21.1°C), exposure time (i.e., time at internal temperature above 50°F (10°C) but below 135°F (57.2°C)) should be limited to 2 hours;
• Alternatively, exposure time (i.e., time at internal temperatures above 50°F (10°C) but below 135°F (57.2°C)) should be limited to 4 hours, as long as no more than 2 of those hours are between 70° F (21.1°C) and 135° F (57.2°C).
2. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123. 7(b). However, your corrective action plan for your frozen, (b)(4) packaged salted and dried herring products at the "(b)(4)" and "(b)(4)" critical control points are not appropriate. In addition to preventing the distribution of adulterated product by disposing of products that fail to meet your critical limits, you must also ensure the cause of the deviation has been corrected.
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 deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan or plans 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 products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
If you do not respond 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.
You should direct your written reply to 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 email@example.com. Please reference case# 589565 on any submissions and within the subject line of any emails to us.
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition