- Hashimoto Shokuryo Kogyo 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 |
MAR 4, 2015
VIA EXPRESS DELIVERY
Mr. Hashimoto Toshikatsu, President
Hashimoto Shokuryo Kogyo Co. Ltd
Ibaraki City, Osaka
Reference No. # 451034
Dear Mr. Hashimoto Toshikatsu:
The U.S. Food and Drug Administration (FDA) inspected your low-acid canned food (LACF) firm, Hashimoto Shokuryo Kogyo Co. Ltd., located at 2-17-29 Sawaragi-Nishi, Ibaraki City, Osaka 567-0868 Japan, on September 1 and 2, 2014. During that inspection, we found that your firm had serious deviations from the Emergency Permit Control regulation (Title 21, Code of Federal Regulations, Part 108 (21 CFR 108)) and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations that lists the serious deviations found at the firm. We acknowledge receipt of your responses received via email dated September 16, 2014, January 8, 2015, and February 19, 2015, which included documentation describing corrections to the observations of concern noted on the form FDA-483; however, our evaluation of the documentation revealed that the responses were not adequate, as further described in this letter.
As a manufacturer of LACF products intended for export to the United States, you are required to comply with the Food, Drug and Cosmetic Act (the Act) and the federal regulations relating to the processing of low-acid foods packaged in hermetically sealed containers. The Emergency Permit Control regulations were issued, in part, pursuant to section 404 of the Act, Emergency Permit Control, 21 U.S.C. § 344. A temporary emergency permit may be required for thermally processed low-acid foods packaged in hermetically sealed containers whenever a processor has failed to fulfill the requirements of 21 CFR 108.35, including registration and filing of process information, and the mandatory requirements in 21 CFR Parts 113. Regulations specific to the processing of LACF products are described in 21 CFR 108 and 21 CFR 113. As outlined in these regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR 108.35 and 21 CFR 113 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 108.35(k), 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. Violation of the mandatory requirements set forth in 21 CFR 108.35 and 21 CFR 113 renders your LACF products 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 LACF regulations through links in FDA’s home page at www.fda.gov
Your significant violations are as follows:
1. A commercial processor of low-acid foods is required, not later than 10 days after first engaging in the manufacture, processing, and packaging of thermally processed low-acid foods in hermetically sealed containers 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, as required by 21 CFR 108.35(c)(1) and, not later than 60 days after registration and prior to the packing of a new product, provide the Food and Drug Administration information as to the scheduled processes including but not limited to the processing method, type of retort or other thermal processing equipment employed, minimum initial temperatures, times and temperatures of processing, sterilizing value, or other equivalent scientific evidence of process adequacy, critical control factors affecting heat penetration, and source and date of the establishment of the process, for each such low-acid food in each container size, to comply with 21 CFR 108.35(c)(2).
We acknowledge that your firm used to hold food canning establishment (FCE) registration number 05693. However, that registration was voided by the FDA on October 30, 2014, because the mail we sent to you at the mailing address you provided to us with your firm’s FCE registration was returned as undeliverable. The mailing address we had on file is 300 Sawaragi Nishi, Ibaragi Osaka-Fu, Japan. The voiding of the FCE registration also voids all the schedule processes on file; therefore, the following SIDS are invalid: (b)(4). A review of shipment data reflects that your firm’s LACF products have continued to be offered for import into the United States as recently as January 23, 2015 (entry number (b)(4)).
2. Your firm failed to ensure that the temperature of the product is no lower than the minimum initial temperature specified in the filed scheduled process as required by 21 CFR 113.87(c). Specifically, our investigator observed on September 1, 2014 and determined through review of records for May 15, 2014 that your firm does not determine the initial temperature for each retort load of LACF product, but rather documents the initial temperature only twice per day independent of the retort used. Your responses dated September 16, 2014, January 8, 2015, and February 19, 2015 stated that you will correct this deviation and you provided records from a single day, February 5, 2015, reflecting correction. FDA recommends firms to submit records from five or more production days to confirm corrections and to demonstrate adherence to critical factors identified in the filed scheduled process.
3. Your firm failed to identify, from processor check or otherwise, deviations from the filed scheduled process or critical factors which are out of control as required by 21 CFR 113.89. Specifically, our inspection revealed the following deviations from the filed scheduled process in products for export to the United States and these were not included in your firm's deviation file:
a. The following deviations from the scheduled process/critical factors found during record review occurred during thermal processing of (b)(4):
i. The maximum fill weight stated on the scheduled process for this product is (b)(4); however, on May 15, 2014 the maximum fill weight was exceeded in (b)(4) cans weighed.
ii. The "syrup strength" stated on the scheduled process for this product is (b)(4); however, on May 15 and 16, 2014 the degree brix measurements (b)(4).
b. The following deviation from the scheduled process/critical factors was observed to occur on September 1, 2014 during thermal processing of (b)(4):
i. The maximum fill weight stated on the scheduled process for this product is (b)(4); however, the maximum fill weight was exceeded in (b)(4) weighed.
ii. The "syrup strength" stated on the scheduled process for this product is (b)(4); however, the degree brix measurements (b)(4).
Your responses dated September 16, 2014, January 8, 2015, and February 19, 2015 stated that you will no longer (b)(4) when manufacturing in the future, are now using an automatic weight checker, and you provided records from a single day, February 5, 2015, reflecting correction. FDA recommends firms to submit records from five or more production days to confirm corrections and to demonstrate adherence to critical factors identified in the filed scheduled process.
Your firm failed to mark each hermetically sealed container of low-acid processed food with an identifying code that shall be permanently visible to the naked eye as required by 21 CFR 113.60(c). The required identification shall identify in code the establishment where packed, the product contained therein, the year packed, the day packed, and the period during which packed. Specifically, our inspection revealed the manufacturing codes on your low-acid canned food products merely reflect the expiration date and the location packed. You stated in your response that you will correct this deviation and you provided records from a single day, February 5, 2015, reflecting correction. FDA recommends submission of records from five or more production days and information on how your firm intends to maintain compliance with the identification code requirement to confirm correction to this particular observation.
Your firm failed to perform and record teardown examinations at intervals of sufficient frequency on containers from your seaming station to ensure maintenance of seam integrity as required by 21 CFR 113.60(a)(1). Specifically, our investigator observed on September 1, 2014, and determined through review of records for May 15, 2014 that your firm conducts a teardown examination on only one can per lot number on the day after production. In addition, your examination does not include the measurement of cover hook length, body hook length, and tightness as required by 21 CFR 113.60(a)(1)(i)(a). Your responses September 16, 2014, January 8, 2015, and February 19, 2015 stated that you will correct this deviation and you provided records from a single day, February 5, 2015, reflecting correction. FDA recommends submission of records from five or more production days and information on how your firm intends to maintain compliance with this container integrity testing requirement to confirm correction to this observation.
4. Processing and production information is not entered on your production records at the time it is observed as required by 21 CFR 113.100(a). Specifically, on September 1, 2014, our investigator observed that your retort operator pre-recorded the ending time of the thermal process for (b)(4). Your response stated that you will correct this deviation and you provided records from a single day, February 5, 2015, reflecting correction. FDA recommends submission of records from five or more production days and a description of the retraining of relevant staff to confirm correction.
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 violations and should include documentation that would assist us in evaluating your corrections. Responding in English will help to assist us in our review of your documentation. 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 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 acidified and LACF 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 LACF and acidified food regulations (21 CFR 108, 113, 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
This letter may not list all the violations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable regulations, including the LACF regulations (21 CFR 108 and 113) 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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for reinspection-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 reinspection-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: Catherine Vieweg, Compliance Officer, Food Adulteration Assessment Branch, Division of Enforcement, Office of Compliance, Center for Food Safety and Applied Nutrition, HFS-607, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. You may submit documentation accompanying your reply to: Catherine.Vieweg@fda.hhs.gov
. Please reference #451034 on any submissions and within the subject line of any emails to us. You may also contact Catherine Vieweg via email if you have any questions about this letter.
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition
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