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WARNING LETTER

Rongcheng Shidao Guangxin Food Co., Ltd. Apr 11, 2014

Rongcheng Shidao Guangxin Food Co., Ltd. - 04/11/2014


Recipient:
Rongcheng Shidao Guangxin Food Co., Ltd.


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 

APRIL 11, 2014

WARNING LETTER

VIA EXPRESS DELIVERY
 

Mr. Xiao Xuejun
General Manager
Rongcheng Shidao Guangxin Food Co., Ltd.
No 227 Longteng North Road
Shidao Industrial Park
Rongcheng, China 264309
 

Re: 422248

Dear Mr. Xiao:

We inspected your low-acid canned seafood processing facility, Rongcheng Shidao Guangxin Food Co., Ltd., located at No 227 Longteng North Road, Shidao Industrial Park, Rongcheng, China, 264309 on December 2-4, 2013. At the conclusion of that inspection, our investigator issued an FDA Form 483, a form listing the observations of concern noted during the inspection. During that inspection we found that you had serious violations of the low-acid canned food regulations (LACF), Title 21, Code of Federal Regulations, Part 113. We have not received a response to the FDA 483 from your firm.

As a manufacturer of low-acid canned seafood products, you are required to comply with the U.S. Federal Food, Drug, and Cosmetic Act (the Act), and the federal regulations relating to the processing of low-acid canned food products for the low-acid canned foods that you export to the United States. These regulations are described in 21 CFR 108, Emergency Permit Control, and 21 CFR 113, Thermally Processed Low-Acid Foods Packaged in Hermitically Sealed Containers. 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 (see additional information elsewhere in this letter). Consequently, your violations of the mandatory requirements set forth in 21 CFR 108.35 and 21 CFR 113 render your low-acid canned food products adulterated within the meaning of Section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4).

During the inspection, the FDA investigator also collected labels from your products. Our review finds that some of your products are misbranded within the meaning of Section 403(i)(2) of the Act, 21 U.S.C. 343(i)(2), in that they do not appropriately list the ingredients in the products.

You can find the Act and the regulations through links in FDA's home page at http://www.fda.gov.

Your significant violations are as follows:

Low-Acid Canned Foods

1.    Records must be maintained to identify the initial distribution of the finished product to facilitate the segregation of specific food lots that may have become contaminated or otherwise rendered unfit for their intended use, to comply with 21 CFR 113.100(f). However, your shipping records identified product shipped using one lot number, but the products shipped actually included three different lots.

2.    Container handling equipment must be checked with sufficient frequency and repaired or replaced as necessary to prevent damage to containers and container closures, to comply with 21 CFR 113.60(d). Further, regular observations must be maintained during production runs for gross closure defects, to comply with 21 CFR 113.60(a). However, field examinations on filled and empty 300x407 size cans found 10 out of 105 cans examined with poorly welded and rusted side seams and one can with a damaged end seam; 50 out of 50 cans examined with observable dents on can bodies and next to both end seams; 7 out of 55 empty cans with apparent bubble, rough coating and/or poor side seam welds.

3.    Results of can seam teardown examinations must be recorded at sufficient frequency to ensure maintenance of seam integrity and corrective actions noted, to comply with 21 CFR 113.60(a)(1). However, your firm's can seam teardown records for 300x407 cans did not always identify corrective actions taken for measurement values recorded for body hook which were out of specification.

4.    Scheduled processes for low-acid foods shall be established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers, to comply with 21 CFR 113.83. The type, range and combination of variations encountered in commercial production shall be adequately provided for in establishing the scheduled process. Variations include those that occur due to seasonal or growing fluctuations, variety differences, supplier processes, reprocessing and mixing a batch of processed product with the same unprocessed product before it is processed. However, your filed scheduled process for sardines in oil does not specify a maximum length of time that filled containers can be held prior to reprocessing. Also, your firm does not record the length of time that cans identified as having possible seam defects and held for later processing of the contents are held prior to reprocessing.

Labeling

Your Hyper Harbor brand for Sardines in Tomato Sauce with Chili and Hyper Harbor brand for Sardines in Brine are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because you failed to declare on the label the acceptable market name in your list of ingredients for the fish you use. Specifically, you stated to our investigator at the time of inspection that you process Clupea pallasi (Pacific Herring) to be sold as sardines. The acceptable market name for Pacific Herring is Herring, Sea Herring, Sild, but in your list of ingredients, you declare "Sardines," which is not in accordance with 21 CFR 101.4(b). You may find the acceptable market names on the FDA Seafood List, located on FDA's website.

You should respond in writing within 15 working days from your receipt ofthis letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation, such as at least five (5) days of production records, to demonstrate that you have implemented the revisions indicated in your response and any other useful information 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 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 low-acid canned 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 low-acid canned food regulations (21 CFR 108 and 113) is Import Alert #99-04. This alert can be found on FDA's web site at: http://www.fda.gov/Forlndustry/lmportPrograrn/lmportAlerts/default.htm2.

This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the low-acid canned food regulations (21 CFR Parts 108 and 113), the Current Good Manufacturing Practice regulation (21 CFR Part 110), and the labeling regulations (21 CFR Part 101). 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 ofthe 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 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. 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.

In addition to the deviations noted above, we have the following additional comments regarding your manufacturing and labeling:

Low-acid canned foods:

1.    Your retort operator logs do not always identify the correct number of cans in each retort load.

2.    Excessive steam in processing room during venting of retorts caused retort operator's reference wall clock to not be observable from more than 6 feet away.

Labeling:

1.    Your Hyper Harbor brand label for Sardines in Tomato Sauce with Chili and Hyper Harbor brand label for Mackerel in Tomato Sauce are fabricated from two or more ingredients but the labeling fails to bear a complete list of all of the ingredients by common or usual name in descending order of predominance by weight, as well as subingredients, as required by 21 CFR 101.4. For example:

a.    The ingredient statements for both declare tomato sauce, which is a multiingredient food. However, the labels do not declare the presence of the subingredients in this multi-component food in accordance with 21 CFR 101.4(b)(2). According to the product formulation collected during the inspection, your product does not list the following sub-ingredients of the tomato sauce: water, tomato paste, sugar, starch, salad oil, salt and xanthan gum.

b.    Your Hyper Harbor brand label for Sardines in Tomato Sauce with Chili declares "chili" in the list of ingredients. The term "chili" is not a specific name, but instead a collective (generic) name that could imply foods other than chili peppers or chilies [21 CFR 101.4(b)(2)].
 

The requirement to list component ingredients (or "sub-ingredients") may be met by either parenthetically listing the component ingredients after the common or usual name of the multi-component ingredient, or by listing the component ingredients without listing the multi-component ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multicomponent ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food [21 CFR 101.4(b)(2)].

2.    Your product contains the species Konosirus punctatus. This species is not listed in The Seafood List at present, but FDA plans to include with our next update with the acceptable market name "gizzard shad" and common name "dotted gizzard Shad." Therefore, we recommend that the name "Shad" should be listed in the ingredient statement when the fish Konosirus punctatus is processed as sardines.

Please send your reply to the U.S. Food and Drug Administration, Attention: Donald W. Greaves, Consumer Safety Officer, Office of Compliance, Division ofEnforcement, 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 Mr. Greaves at (240) 402-2057 or via email at donald.greaves@fda.hhs.gov
 

Sincerely,
/S/
Amy Barringer
Acting Director
Office of Compliance
Center for Food Safety
     and Applied Nutrition

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