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WARNING LETTER

January 5, 2022

Re: CMS # 618038

Dear Mr. Sung Yoon Yong,

On August 11 to August 25, 2021, the Food and Drug Administration (FDA) conducted a remote Foreign Supplier Verification Program (FSVP) inspection of HK Produce Group Inc. DBA Y2S Trading Inc. located at 3109 Starr Avenue, Long Island City, NY 11101. This inspection was 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.

This inspection was initiated, in part, based on FDA samples finding Listeria monocytogenes (L. monocytogenes), a human pathogen, in four (4) entries of fresh enoki mushrooms, three (3) of which were from (b)(4) located in (b)(4) and one (1) from (b)(4) located in (b)(4). The samples were collected from entries B7S-2105311-2, 677-0332940-8, 677-0332919-2 and B7S-2106092-7, all imported by your firm. We placed fresh enoki mushrooms from (b)(4) under Import Alert (IA) #99-23 “Detention Without Physical Examination of Produce Due to Contamination With Human Pathogens,” on July 20, 2021 and IA #99-35 “Detention Without Physical Examination of Produce That Appears To Have Been Prepared, Packed, Or Held Under Insanitary Conditions,” on November 1, 2021. We also added fresh enoki mushrooms from (b)(4) to IA #99-23 on September 17, 2021. Therefore, when you import these foods subject to DWPE per these identified IAs they are subject to refusal of admission pursuant to Section 801(a)(3) in that the food appears to be adulterated per the respective IA. This information should be taken into consideration when you are evaluating your suppliers and developing your FSVP. You can find DWPE information relating to IAs at https://www.accessdata.fda.gov/cms_ia/ialist.html.

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 inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the foods you import, including fresh enoki mushrooms imported from (b)(4) located in the (b)(4), fresh enoki mushrooms imported from (b)(4) located in the (b)(4), and fresh enoki mushrooms imported from (b)(4) located in the (b)(4). Your firm did not have FSVPs for these foods. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.

At the conclusion of the inspection, our investigator provided you with a Form FDA 483a FSVP Observations. However, to date, we have not received your response to the Form FDA 483a for your FSVP violations.

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 imported, including each of the following foods:
  o Fresh enoki mushrooms imported from (b)(4) located in the (b)(4)
  o Fresh enoki mushrooms imported from (b)(4) located in the (b)(4)
  o Fresh enoki mushrooms imported from (b)(4) located in the (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 any 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 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 working 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: David Trent-Carlson, Compliance Officer, Division of Northeast Imports: [email protected]. Please also cc (carbon copy) [email protected]. If you have any questions regarding this letter, you may contact Compliance Officer Trent-Carlson via email at [email protected]. Please reference CMS # 618038 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.

Sincerely,
/S/

Theresa Smedley
Acting Program Division Director
Division of Northeast Imports