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  5. YAMAHARU COMPANY - 438001 - 09/24/2014
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United States

Issuing Office:
Center for Food Safety and Applied Nutrition

United States


Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 College Park, MD  20740 

SEP 24 2014



Yasuhiro Yamazaki, President
Yamaharu Company
5-2-1 Tsukiji, Chuo-Ku
Tokyo, Japan 104-0045

Reference# 438001

Dear Mr. Yamazaki:

The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility Yamaharu Company located 5-2-1 Tsukiji, Chuo-Ku,Tokyo, Japan on April 1-2, 2014. During that inspection, we found that you had 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, Inspectional Observations, listing the observations made at your firm.

We acknowledge receipt of your response sent via email on July 10, 2014. Your response included your firm's revised HACCP plan for fresh sea foods (i.e., for histamine forming fish species), as well as additional documentation.

In accordance with 21 CFR 123.6(g), 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 or 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 scombrotoxin (histamine) forming fish including your mackerel products are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.

You may find the Act, the seafood HACCP regulation and the 4th Edition ofthe Fish and Fishery Products Hazards and Controls Guidance (the Hazards Guide) through links on FDA's home page at www.fda.gov. The Hazards Guide, which provides our recommendations regarding identification and control of food safety hazards reasonably likely to occur for your fish and fishery products, can be found on our web site at: www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatorylnformation/Seafood/ucm2018426.htm.

Your significant deviation is as follows:

1.    You must have a HACCP plan that, at a minimum, lists the critical limits, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm's HACCP plan for fresh sea foods provided with your July 10, 2014, response lists critical limits that are inadequate at the "(b)(4)" critical control point to control scombrotoxin (histamine) formation. Specifically, your plan lists at the packing critical control point, "The work in the packing room do not (b)(4)." Your plan also lists the temperature of the packing room as (b)(4) with no corresponding critical limit for time when fish are exposed to temperatures between (b)(4). FDA recommends that fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 4 hours, cumulatively, if any portion of that time is at temperatures above 70°F (21.1°C). The (b)(4) listed at temperatures over 25°C during packing is considered part of a full 4 hour cumulative time period for unrefrigerated processing.

2.    You must have a HACCP plan, that at a minimum, lists monitoring procedures and their frequency, to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan provided with your July 10, 2014, response lists monitoring procedures at the "(b)(4)" critical control point that are not adequate to control histamine formation. Specifically, your plan lists that you will monitor the temperature of packing room with a thermometer at the time of starting and time of closing; and time to pack using a clock in packing room at time of starting and time of closing. This is not adequate to ensure that your firm consistently meets the corresponding critical limits to ensure that the fish are not held in the packing room held at a temperature of (b)(4). FDA recommends your firm monitor the length of time each scombrotoxin (histamine) forming fish is exposed to unrefrigerated conditions (i.e., above 40°F (4.4°C)).

3.    Because your firm 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 fresh sea food is not adequate as further described below.

a.    At the "(b)(4)" critical control point (i.e., internal temperature step) your firm's plan lists returning the lot. In addition, FDA recommends your firm address the source of the deficiency, the supplier. For example, increase the sampling frequency or discontinue use of the supplier until evidence is obtained that transportation conditions have been corrected.
b.    At the "(b)(4)" critical control point, your firm's plan lists, "(b)(4)" In addition, FDA recommends your firm hold the affected lot until histamine analysis is performed on a minimum of 60 fish representatively collected from throughout the affected lot or destroy the lot or divert to a non-food use if any fish is found with histamine greater than or equal to 50 ppm. FDA also requires you take corrective actions to regain control over the operation after a critical limit deviation, address the root cause, and modify the process as needed to reduce the time and temperature exposure.

You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking 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, 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 ofthe 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 do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported fish or 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: www.accessdata.fda.gov/cms_ia/ialist.html.

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 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 there-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.

This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the seafood HACCP regulation, and the Good Manufacturing Practice regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Please send your reply to Food and Drug Administration, Attention: Standra Purnell, Compliance Officer, Food Adulteration Assessment Branch (HFS-607), Division of Enforcement, Office of Compliance, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Purnell via email at standra.purnell@fda.hhs.gov.

William A. Correll
Office of Compliance
Center for Food Safety
    and Applied Nutrition

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