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  5. Lemond Trading Corp - 598229 - 02/10/2020
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WARNING LETTER

Lemond Trading Corp MARCS-CMS 598229 —

Delivery Method:
United Parcel Service
Product:
Food & Beverages
Recipient:
Recipient Name
Nam Ho Kang
Recipient Title
General Manager
Lemond Trading Corp

4461 Malaai St.
Honolulu, HI 96818
United States

Issuing Office:
Division of West Coast Imports

United States

WARNING LETTER

February 10, 2020

Re: CMS # 598229

Dear Mr. Nam Ho Kang:

On November 25 and 26, 2019, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection at Lemond Trading Corp., 4461 Malaai Street, Honolulu, HI 96818. We also conducted an inspection on July 24, 2018. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the Foreign Supplier Verification Program (FSVP) implementing regulation in 21 CFR part 1 subpart L.

The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.

During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for your FSVPs for any food products you import including but not limited to, red pepper powder, frozen noodles, frozen fried rice, soup stock, assorted frozen dumpling, assorted buns,
frozen fried seaweed, cookies, soy bean paste, fried soybean curd, fried seaweed wrapped vermicelli rolls, and seasonings from your foreign supplier, (b)(4), located in the (b)(4). Because of these significant violations, you are not in compliance with section 805 of the FD&C Act. At the conclusion of both the initial FSVP inspection, and the follow-up inspection on November 25-26, 2019, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.

We acknowledge receipt of your response dated November 27, 2019 where you included a statement that you will appoint a person to develop an FSVP as soon as possible. In your letter, you asked for guidance on where to find information on the requirements for FSVP. During the inspection our investigator provided you with documents entitled, “FSVP Final Rule on Foreign Supplier Verification Programs,” and “Key Requirements on Foreign Supplier Verification Programs,” which explained the requirements to you. However, your response is inadequate because you did not provide details or timeframes as to when you will complete and implement FSVP requirements for all of the foods that you import.

Your significant deviation is described below:

You did not develop FSVPs as required by section 805 of the FD&C Act and 21 CFR part 1 subpart L. Specifically, your firm did not develop FSVPs for the foods that you imported under entry EPM-0152012-7.

The above violation is not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1 subpart L.

You should take prompt action to correct the above violations. If you do not promptly correct them, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of any of the food products imported from any foreign supplier, including (b)(4), including placing the food from the identified foreign supplier on detention without physical examination (DWPE) when you import the product. You can find DWPE information relating to FSVP in Import Alert #99-41 at http://www.accessdata.fda.gov/cms_ia/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct these violations. You should include in your response documentation and information that would assist us in evaluating your corrections, (e.g.,
documentation of changes you made, such as a copy of your revised FSVP, records to demonstrate implementation of your FSVP, and any additional information that you wish to supply relevant to your compliance with the FSVP regulation.) If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. 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.

Please send your reply to Food and Drug Administration, Attention: Deborah W. Hsu, Compliance Officer, Division of West Coast Imports, 1 World Trade Center, Suite 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact Deborah Hsu via email at deborah.hsu@fda.hhs.gov. Please reference CMS # 598229 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.

Sincerely,
/S/

Dan R. Solis
Program Division Director
Division of West Coast Imports

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