- Tokushima Seihun Co, LTD.
- Issuing Office:
- Center for Food Safety and Applied Nutrition
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||College Park, MD 20740 |
NOV 7, 2016
VIA EXPRESS DELIVERY
Mr. Yoshiaki Higashi, Plant Manger
Tokushima Seihun Co, LTD.
Ikawadanai-Cho, No. 650-1-2f, Arise 650-1-1f
Nishi-Ku Kobeshi, Hyogo, 6512113
Dear Mr. Higashi:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your acidified food facility, Tokushima Seihun Co, LTD.located at Ikawadanai-Cho, No. 650-1-2f, Arise 650-1-1f, Nishi-Ku Kobeshi, Hyogo, 6512113, Japan, on July 27 -28, 2016. That inspection revealed serious violations of the Emergency Permit Control regulation (Title 21, Code of Federal Regulations, Part 108 (21 CFR 108)) and the Acidified Foods regulation (21 CFR 114). That inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, listing the deviations found at your firm at the conclusion of the inspection. Your response received via email dated August 19, 2016 included documentation describing corrections to the observations of concern noted on the form FDA-483. However, our evaluation of the documentation revealed that the response was not adequate, as further described in this letter.
In accordance with 21 CFR 108 and 21 CFR 114, failure of a acidified food (AF) facility to operate in accordance with the requirements of 21 CFR 108 and 21 CFR 114, renders the acidified food 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 acidified food products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. Additionally, the failure of an AF facility to all of the mandatory requirements of 21 CFR 108.25, and 21 CFR 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 a 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. You may find the Act, 21 CFR 108 and 21 CFR 114 through links in FDA's home page at www.fda.gov
We note the following significant deviations:
1. You must file the scheduled processes with the FDA for each acidified food in each container size to comply with 21 CFR 108.25(c)(2). This filing must occur not later than 60 days after registration and prior to the packing of a new product and include conditions for heat processing; 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. Specifically, your firm did not provide FDA with the scheduled processes for your udon noodles, a product which our inspection revealed is an acidified food based on your process which is to add acid to the udon noodles to achieve a shelf stable hermetically sealed product. During the inspection your firm was unable to identify the name in English of the acid you use, however, review of the entry documents associated with the most recent importation of your product revealed the acid is identified in English as lactic acid.
In addition, you must, not later than 10 days after first engaging in the manufacture, processing, and packaging of acidified foods in any state, as defined in section 201(a)(1) of the Act, to register and file a Form FDA 2541 (Food Canning Establishment Registration) with the FDA, to comply with 21 CFR 108.25(c)(1). Specifically, your firm has not registered with the FDA as an acidified food manufacturer, processer or packer.
Your response is inadequate because you did not specifically address registering and filing these processes and your firm with the FDA including an expected date.
Scheduled process information for acidified foods must be submitted on Form FDA 2541e (Food Process Filing for Acidified Method). More information on registration and filing can be found in the publication “Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format” available at: http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm309376.htm
2. You must provide the FDA with the process and procedure information deemed necessary to determine the adequacy of the scheduled process for your acidified foods to comply with 21 CFR 108.35(c)(3)(ii). Specifically, these documents were requested but were not provided to our investigator during the inspection for your udon noodles product.
Your response is inadequate because you did not provide the process and procedure information to determine the adequacy of the scheduled process.
3. You must have plant personnel involved in acidification, pH control, heat treatment, or other critical factors of the operation under the operating supervision of a person who has attended a school approved by FDA to comply with 21 CFR 114.10. Specifically, our inspection revealed no one at your manufacturing factory has received training in pH controls and critical factors in acidification.
Your response is inadequate because you did not specifically address attendance by firm personnel including an expected date.
4. You must exercise sufficient control including frequent testing so that the finished equilibrium pH values are not higher than 4.6 to comply with 21 CFR 114.80(a)(2). Specifically, the inspection revealed your firm measures pH immediately after adding the acid rather than waiting to ensure you are taking an equilibrium pH of your udon noodle product.
Your response is inadequate because it did not include any actual processing records that demonstrate your implementation of your new pH monitoring procedures and adherence to your firm’s scheduled process.
5. You must examine containers often enough to ensure that containers suitably protect the food from leakage or contamination to comply with 21 CFR 114.80(a)(4). Specifically, the inspection revealed your firm did not conduct any routine container testing other than a visual examination.
Your response is inadequate because it did not include details of routine destructive testing of filled, sealed containers and any actual processing records that demonstrate your implementation of your new procedure to test one container per lot.
6. You must mark each container with an identifying code specifying the establishment where the product was packed and the product contained therein, year, day and packing period to comply with 21 CFR 114.80(b). Specifically, the manufacturing code displayed on your labels only identifies an expiration date and does not identify the establishment where the product was packed and the product contained therein, year, day and packing period.
We acknowledge your response letter to the FDA 483, email dated August 19, 2016. The response is inadequate because it does not specify your new coding nor provide an example or any actual processing records that demonstrate your implementation of your new coding.
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 processing records for five lot of product produced over at least five days. 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. Responding in English will help to assist us in our review of your documentation.
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 imported udon noodles product 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 acidified food regulations (21 CFR 108 and 114) is Import Alert 99-37, Detention without Physical Examination of Low-Acid Canned Foods and Acidified Foods without Filed Scheduled Processes. This alert can be found on FDA’s web site at: www.accessdata.fda.gov/cms_ia/ialist.html
In addition to the above deviations, please be aware that the calibration of the thermometer used to monitor your pasteurization should be repeated as necessary. We acknowledge your response included records demonstrating your firm’s calibration of the thermometer used to monitor the temperature of the pasteurizer; however, we note that calibration should occur as frequent as necessary to adequately maintain the equipment in accordance with current Good Manufacturing Practices (21 CFR 110).
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 Acidified regulations (21 CFR 108 and 114), and the current Good Manufacturing Practices regulation (21 CFR 110). 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: Catherine Vieweg, 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 Catherine Vieweg via email at Catherine.Vieweg@fda.hhs.gov
. Please reference 507800 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