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March 28, 2022

Re: CMS # 623164

Dear Ms. Fujimoto,

On November 10, 2021, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of LECS USA, Inc. located at 1410 Boyd St. Los Angeles, CA 90033. We also conducted an inspection on June 19, 2019. 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 implementing FSVP 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 the foods you import. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.

At the conclusion of the inspection on November 10, 2021, our investigator provided you with a Form FDA 483a, FSVP Observations.

We acknowledge receipt of your response dated November 29, 2021, which stated that “LECS USA INC annual sale is under one million dollars and counted as a very small importer.” During the most recent inspection, you also stated that your firm is a very small importer and that you would request a letter of guarantee from your foreign suppliers and provide a written statement that you are following the very small importer requirements. We are unable to evaluate the adequacy of your response because you did not provide documentation that your firm meets the definition of a very small importer (see 21 CFR 1.500 for the definition of a very small importer). You may choose to document your eligibility with tax forms or other accounting documents. You may find information on documenting your eligibility as a very small importer and the other requirements under 21 CFR 1.512 in the “Draft Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals” at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-foreign-supplier-verification-programs-importers-food-humans-and-animals.

Furthermore, even if you meet the definition of a very small importer, you are still required to follow FSVP requirements, including the requirements in sections 1.502, 1.503, and 1.509, but you are not required to comply with the requirements in sections 1.504 through 1.508 or 1.510 (see 21 CFR 1.512(b)(2)). If you choose to comply with the requirements for very small importers, you must document that you meet the definition of a very small importer in 21 CFR 1.500 before initially importing food as a very small importer and thereafter on an annual basis by December 31 of each calendar year (21 CFR 1.512(b)(1)(i)(A)). In addition, for each food you import, you must obtain written assurance, before importing the food and at least every two years thereafter, that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the FD&C Act, if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) (if applicable) of the FD&C Act (see 21 CFR 1.512(b)(3)(i)).

Your significant violations of the FSVP regulation are as follows:

You did not develop, maintain, and follow an FSVP, as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop an FSVP for any of the foods you import, including (b)(4) Green Tea imported from your foreign suppliers, (b)(4).

The above violations are 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.

This letter notifies you of our concerns and provides you an opportunity to address them. If you do not adequately address this matter, 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 the food you import for which you appear to be in violation of section 805. We may place the foods you import into the United States on detention without physical examination (DWPE) when you import the foods. 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 (21 U.S.C. 331(zz)).

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 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 your products 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: Courtney Warren, Compliance Officer, Division of West Coast Imports, 1201 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding this letter, you may contact Courtney Warren via email at Courtney.Warren@fda.hhs.gov. Please reference CMS # 623164 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/

Kathleen Turner, DVM
Program Division Director
Division of West Coast Imports