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July 19, 2023

WARNING LETTER

Re: CMS Case # 656066

Dear Ms. Chen,

From February 15 through February 23, 2023, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Programs (FSVP) inspection at La Yongjia Trade Co. located at 2370 48th Street, Vernon, CA 90058. 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 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.

The inspection was initiated due to findings of Listeria monocytogenes in samples of fresh enoki mushrooms from your foreign suppliers, (b)(4), located in (b)(4), (b)(4), located in (b)(4), (b)(4) and (b)(4), located in (b)(4), (b)(4), located in (b)(4), and (b)(4), located in (b)(4), collected and analyzed by FDA and imported by your company. Your foreign suppliers, (b)(4) were placed on Import Alert # 99-23, Detention Without Physical Examination of Fresh Produce Due to Contamination with Human Pathogens, on July 18, 2022, September 23, 2022, June 17, 2022; February 3, 2023, and September 23, 2022, respectively. Fresh enoki mushrooms from your foreign supplier (b)(4) were placed on Import Alert # 99-35, Detention Without Physical Examination of Fresh Produce that Appears to have been Prepared, Packed, or Held under Insanitary Conditions, on June 14, 2022, respectively. We also note that fresh enoki mushrooms from your foreign suppliers (b)(4) and (b)(4) were placed on Import Alert #99-35 on March 13, 2023.

During the inspection, we found that you were not in compliance with the requirements of 21 CFR part 1 subpart L for the foods you import. At the conclusion of the inspection, our investigator provided you with a Form 483 FSVP Observations. We have not received your response to the Form FDA 483 issued on February 23, 2023.

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 Mushrooms from foreign manufacturer and supplier (b)(4), located in (b)(4).
    o Fresh Enoki Mushrooms from foreign manufacturer (b)(4) and foreign manufacturer and supplier (b)(4), located in (b)(4).
    o Fresh Enoki Mushrooms from foreign manufacturer (b)(4) and foreign manufacturer and supplier (b)(4), located in (b)(4).
    o Fresh Enoki Mushrooms from foreign manufacturer and supplier (b)(4), located in (b)(4).
    o Fresh Enoki Mushrooms from foreign manufacturer (b)(4) and foreign manufacturer and supplier (b)(4), located in (b)(4).

During the inspection, you provided the investigator with sample analysis results for some of the shipments of your Fresh Enoki Mushrooms. You told our investigator that these documents were not intended to be FSVPs, that you do not have a hazard analysis or supplier evaluation procedures/activities, and that you do not have an FSVP for any of the foods you import. To the extent the documents you provided are relevant to an FSVP, they are incomplete, and you did not provide a record of your review of the relevant documents or explain how they would apply to your FSVP program. Thus, these documents do not constitute an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a).

As our investigator explained during the inspection, the FSVP regulation generally requires that you conduct a written hazard analysis (21 CFR 1.504), evaluate your foreign supplier’s performance (21 CFR 1.505), and conduct foreign supplier verification activities (21 CFR 1.506), among other requirements.

Our investigator also explained that 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.

This letter notifies you of our concerns and provides you an opportunity to address them. 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 Fresh Enoki Mushrooms and any other foods you import for which you appear to be in violation of section 805. 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.

In addition, we offer the following comments:

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, or produces food that is adulterated under section 402 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 § 1.506 or § 1.511(c), a reevaluation of the risks posed by the food and the foreign supplier's performance conducted under § 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. If you believe that the foods you import 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: Huy T. Pham, Compliance Officer, 1201 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding this letter, you may contact Huy Pham via email at huy.pham@fda.hhs.gov. Please reference CMS Case # 656066 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/

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