Inspections, Compliance, Enforcement, and Criminal Investigations
Tencho Food Co., Ltd. 12/20/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
College Park, MD
December 20, 2012
VIA EXPRESS DELIVERY
Mr. Masahiro Oghai, Manager
Tencho Foods Co., Ltd.
1-1 Hachimaimono, Kataharaisshiki-cho,
Inazawa-shi, Aichi 492-8355
Reference No.: 383358
Dear Mr. Oghai:
The U.S. Food and Drug Administration (FDA) inspected your acidified food facility located at 1-1 Hachimaimono, Kataharaisshiki-cho, Inazawa-shi, Aichi, 492-8355, Japan on September 6-7, 2012. During that inspection, we found that your firm had serious deviations from the acidified food regulations. These regulations are described in Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR Part 108) and Part 114, Acidified Foods (21 CFR Part 114). As outlined in these regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR 108.25 and 21 CFR Part 114 could be subjected to an immediate application of the emergency permit control provisions of Section 404 of the Act (21 U.S.C. 344). As stated in 21 CFR 108.25(j), for imported products, in lieu of issuing an order of determination that a permit is required before products from such commercial processor can be introduced into interstate commerce, FDA may take steps to refuse admission of the commercial processor’s products under section 801 of the Act (21 U.S.C. 381) when offered for entry into the United States. In addition, your firm had serious deviations from the Current Good Manufacturing Practice regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). Violation of the mandatory requirements set forth in 21 CFR 108.25 and 21 CFR Part 114 and deviations from current good manufacturing practices renders your acidified foods adulterated within the meaning of Section 402(a)(4) of the Act (21 U.S.C. 342(a)(4)). You can find the Act and regulations through links in FDA’s home page at http://www.fda.gov.
At the conclusion of the inspection, FDA issued an FDA-483, Inspectional Observations, which listed the deviations found at your firm. To date, we have not received any written response from you addressing corrective action to those observations.
We have the following concerns with regard to your acidified food products:
- Your firm failed to provide FDA’s Center for Food Safety and Applied Nutrition (CFSAN), within 60 days after registration and before packing any new product, information on the scheduled processes including, as necessary, conditions for heat processing and control of pH, salt, sugar, and preservative levels, and source and date of the establishment of the process for each acidified food in each container size as required by 21 CFR 108.25(c)(2). Specifically, you do not have filed scheduled processes for the following acidified food products you manufacture and distribute to the U.S.:
o Prepared Ginger, Shoga Gohan No Moto, Net Wt. 3.52 oz.
o Pickled Cucumber, Tencho Shiba Zuke, Net Wt. 3.52 oz.
o Prepared Cucumber, Tencho Pirikara Kyuri, Net Wt. 3.52 oz.
o Prepared Radish, Tencho Wariboshi Daikon, Net Wt. 3.52 oz.
o Prepared Vegetable, Tencho Fukujinzuke, Net Wt. 3.52 oz.
o Prepared Ginger & Garlic, Shoga To Ninniku, Net Wt. 3.52 oz.
o Pickled Vegetable, Tencho Takana Chazuke, Net Wt. 3.52 oz.
o Prepared Radish, Tencho Pirikara, Daikon, Net Wt. 3.52 oz.
Your firm is responsible for determining which regulations apply to the products that you manufacture, including whether products you manufacture are considered to be acidified foods, as defined in 21 CFR 114.3(b), subject to the applicable provisions of 21 CFR Parts 108 and 114. Scheduled process information for acidified or low-acid canned foods must be submitted on Form FDA 2541a (Processing Filing for all Processing Methods Except Low Acid Aseptic). More information on registration and filing can be found in the publication, “Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods,” available at: http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/AcidifiedLow-AcidCannedFoods/
In addition, we note that some of your products’ labels (Prepared Cucumber, Pickled Vegetable, and Prepared Radish) include a "Keep Refrigerated" instruction on the label; however, our investigator confirmed that your products are not stored or shipped under refrigerated conditions and that, instead, you intend for your products to be refrigerated after opening.
- Your firm failed to provide process information which was deemed necessary by the FDA to determine the adequacy of that process as required by 21 CFR 108.25(c)(3)(ii). Specifically, you were unable to provide a process source document for your Amasu Ginger (Pickled Ginger) associated with (b)(4), the only scheduled process you currently have on file in the FDA database. This process source document is necessary to demonstrate that the processes and equipment you are using to manufacture this product is based on adequate scientific studies and calculations as your current process on file fails to include a process source, acidification method, and thermal process parameters.
- Your firm’s plant is not constructed in such a manner as to allow floors, walls, and ceilings to be adequately cleaned and kept in good repair as required by 21 CFR 110.20(b)(4). Specifically, floors throughout the production facility and packaging room are in disrepair with cracks and missing pieces of concrete that have allowed for the accumulation of water and organic material. In addition, the walls and ceilings in sterilizing room had an accumulation of mold that is directly above your open hot water sterilizers.
- Your firm’s food-contact surfaces are not corrosion-resistant when in contact with food as required by 21 CFR 110.40(a). Specifically, during the inspection, our investigator observed that the blades on the vegetable slicing machine being used to slice Japanese radish and eggplant had a build-up of rust.
- Your firm failed to provide there is no backflow from, or cross-connection between, piping systems that discharge waste water or sewage and piping systems that carry water for food or food manufacturing as required by 21 CFR 110.37(b)(5). Specifically, piping systems that dispense water through threaded hoses are not fitted with backflow prevention devices to prevent contamination of the water supply.
- Your firm failed to have smoothly bonded or maintained seams on food-contact surfaces so as to minimize accumulation of food particles and organic matter and thus minimizing the opportunity for growth of microorganisms as required by 21 CFR 110.40(b). Specifically, welded seams inside the vegetable wringing machine bin (used to remove water from vegetable) were not smoothly bonded and provided crevices for accumulation of organic matter.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to further correct these violations. You should include in your response documentation that would assist us in evaluating your corrections. 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 acidified food 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 canned food regulations (21 CFR Parts 108, 113, and 114) is Import Alert #99-04. This alert can be found on FDA’s web site at: http://www.fda.gov/ForIndustry/ImportProgram/ImportAlerts/default.htm.
This letter may not list all the violations at your facility. You are responsible for ensuring that you firm operates in compliance with the Act and all applicable regulations, including the acidified food regulations (21 CFR Part 108 and 114) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic 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 U.S. Food and Drug Administration, Attention: Robyn R. Jones, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding any issue in this letter, you may contact Ms. Jones at (240) 402-2575 or via email at firstname.lastname@example.org.
Michael W. Roosevelt
Office of Compliance
Center for Food Safety
and Applied Nutrition