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WARNING LETTER

HH Fresh Trading Corp MARCS-CMS 680768 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Yayun (NMI) Chen
Recipient Title
CEO
HH Fresh Trading Corp

3839 Dozier St
Los Angeles, CA 90063-1827
United States

Issuing Office:
Division of West Coast Imports

United States

July 17, 2024

WARNING LETTER

Re: CMS # 680768

Dear Ms. Chen:

From February 21, 2024, through March 04, 2024, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of HH Fresh Trading Corp, located at 3839 Dozier St., Los Angeles, CA 90063. 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.

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 United States 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-finalrule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.

The inspection was initiated due to FDA laboratory findings of Listeria monocytogenes in a sample of fresh Enoki Mushrooms from your foreign supplier (b)(4) in (b)(4) and imported by your company. On March 6, 2024, you voluntarily destroyed this shipment after FDA notified you that we analyzed a sample collected from the shipment, detected Listeria monocytogenes, and determined the enoki mushrooms were adulterated under section 402 of the FD&C Act.

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. 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.

We acknowledge receipt of your response dated March 21, 2024. Your response described your intended corrective actions and requested a 9-week timeframe for submitting the “Produce Safety Rule Plans” to FDA for review. We are unable to evaluate the adequacy of any corrective actions because you have not provided any supporting documentation demonstrating your planned or completed corrective actions.

Your significant violations of the FSVP regulation are as follows:

1. 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 foods that you import, including the following foods:
  o Fresh Enoki Mushroom from (b)(4) located in (b)(4).
  o Fresh Seafood Mushroom from (b)(4) located in (b)(4).
  o Fresh Bamboo Shoots from (b)(4) located in (b)(4).

You import fresh produce that is “covered produce” as defined in 21 CFR 112.3. As an importer of covered produce, you must have an FSVP that demonstrates that your 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 419 of the FD&C Act (21 U.S.C. 350h) (regarding standards for produce safety) and the implementing regulations in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (21 CFR part 112).

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.

Failure to Register Food Facility:
In addition, FDA has determined that your facility at 2370 E. 48th St, Vernon, CA 90058 is subject to the registration requirement in section 415 of the FD&C Act (21 U.S.C. § 350 d) and our implementing regulations at 21 CFR part 1, Subpart H. Section 415(a)(3) of the FD&C Act requires facilities that are required to register with FDA to renew their registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year. The failure to register a facility as required is a prohibited act under section 301(dd) of the FD&C Act (21 U.S.C. § 331 dd). Our records indicate that as of the date of this letter your firm does not have a valid food facility registration.

As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.

We request that the owner, operator, or agent in charge of this facility, or an individual authorized by this facility’s owner, operator, or agent in charge, register the facility with FDA within 30 working days of the date of this letter. Food facility registration guidance is available online at https://www.fda.gov/food/guidance-regulation-food-and-dietarysupplements/ registration-food-facilities-and-other-submissions. Registration may be accomplished online at http://www.access.fda.gov. You must submit your registration or registration renewal to FDA electronically, unless FDA has granted you a waiver under 21 CFR 1.245 (21 CFR 1.231(a)(4)).

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. We may place the foods you import 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)).

In addition, we offer the following comments:

We note that, based on information available to FDA, you may meet the definition of a very small importer under 21 CFR 1.500. During our inspection, our investigator explained the definition of a very small importer and the modified FSVP records requirements to you. You stated that you are choosing to follow the standard FSVP records requirements because you wanted to comply with everything. If you choose to comply with the modified requirements in 21 CFR 1.512 for very small importers, you must document that you meet the definition of a very small importer, as required per 21 CFR 1.512(b)(1)(i). An importer following the modified requirements would still be required to comply with the requirements in sections 21 CFR 1.502 (concerning the scope of an FSVP), 1.503 (concerning the use of qualified individuals), and 1.509 (concerning identification of the importer at entry). However, you are not required to comply with the requirements in sections 21 CFR 1.504 through 1.508 or 1.510 (see 21 CFR 1.512(b)(2)). 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)).

Further, for the FSVPs you are required to develop, 21 CFR 1.508(a) requires that you must promptly take appropriate corrective actions if you determine that a foreign supplier of food you import does not produce 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 and the implementing regulations, produces food that is adulterated under section 402 or misbranded under section 403(w) of the FD&C Act. This determination could be based on a review of consumer, customer, or other complaints related to food safety, the verification activities conducted under 21 CFR 1.506 or 1.511(c), a reevaluation of the risks posed by the food and the foreign supplier's performance conducted under 21 CFR 1.505(c) or (d), or any other relevant information you obtain. The appropriate corrective actions will depend on the circumstances but could include discontinuing use of the foreign supplier until the cause or causes of noncompliance, adulteration, or misbranding have been adequately addressed. You must document any corrective actions you take in accordance with 21 CFR 1.508(a).

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 will 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. Please provide an English translation of any records that you provide in a language other than English in order to facilitate our review. 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: Celena Ngo, Compliance Officer, Division of West Coast Imports, One World Trade Center, Suite 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact Celena Ngo via email at celena.ngo@fda.hhs.gov. Please reference CMS # 680768 on any documents or records you provide to us and within the subject line of any email correspondence you send to us.

Sincerely,
/S/

Dr. Kathleen Turner
Program Division Director
Division of West Coast Imports

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