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January 6, 2022

WARNING LETTER

Re: CMS # 619065

Dear Mr. Tung:

On July 20 through August 3, 2021, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Concord Farms, Inc. located at 5725 Alcoa Avenue, 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-supplierverification-programs-fsvp-importers-food-humans-and-animals.

Our inspection was initiated in response to the recent recall event associated with mushroom products imported by you from one of your foreign suppliers. Specifically, you were notified by the California Department of Public Health (CDPH) that retail samples of fresh enoki mushroom products, imported from your foreign supplier, (b)(4) located in Korea (Republic of Korea), tested positive for Listeria monocytogenes. In response to these analytical findings, you conducted a voluntary recall of the imported fresh enoki mushroom products on June 29, 2021.

During the inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the following foods you import: fresh enoki mushrooms imported from (b)(4), located in the Republic of Korea, and fresh enoki mushrooms imported from (b)(4), located in the Republic of Korea; oyster mushrooms imported from (b)(4), located in (b)(4); and the foods from the foreign suppliers indicated in the attached list. 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 to the FDA 483a dated August 23, 2021, which stated that you are making the necessary improvements and will gather the information needed by August 27, 2021. However, we are unable to evaluate the adequacy of your response because you did not submit any documents relating to your FSVPs or 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 each of the following foods that you import:

• Ginger Root imported from (b)(4)
• Pear imported from (b)(4)
• Ginger Root imported from (b)(4)
• Bamboo Shoots from (b)(4)
• Ginger Root imported from (b)(4)
• Ginger Root imported from (b)(4)

2. You must conduct a written hazard analysis for each type of food you import to determine whether there are any hazards requiring a control, as required by 21 CFR 1.504(a). Although you may meet your requirement to determine whether there are any hazards requiring a control by reviewing and assessing the hazard analysis conducted by another entity using a qualified individual, you must document your review and assessment of that hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual. Specifically, the document you provided during the inspection states that you relied on a written hazard analysis from your foreign supplier for your oyster mushrooms imported from (b)(4). However, you did not provide FDA with any documentation that you reviewed and assessed your foreign supplier’s hazard analysis as required by 21 CFR 1.504(d).

3. You must approve your foreign suppliers on the basis of an evaluation of your foreign supplier’s performance and the risk posed by the food, in accordance with 21 CFR 1.505(a), for the products you import. In approving your foreign suppliers and determining the appropriate supplier verification activities, you did not consider the foreign suppliers’ procedures, processes, and practices related to the safety of the food, as required by 21 CFR 1.505(a)(1)(iii)(A). Moreover, your evaluation did not consider applicable FDA food safety regulations and information relevant to the foreign supplier’s compliance with those regulations, as required by 21 CFR 1.505(a)(1)(iii)(B). Specifically, your enoki mushrooms imported from (b)(4), shipped to you by (b)(4), your enoki mushrooms imported from (b)(4), and your oyster mushrooms imported from (b)(4), are raw agricultural commodities covered under 21 CFR Part 112, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (the Produce Safety Rule), however, your supplier evaluation and approval records dated July 8, 2021 did not demonstrate consideration of the suppliers’ compliance with the requirements of the Produce Safety Rule.

4. Your supplier verification activities did not provide adequate assurance that the hazards requiring a control in the foods you import have been significantly minimized or prevented, as required by 21 CFR 1.506(c). FDA has determined that the biological hazards in covered produce require a control, and compliance with the requirements in the Produce Safety Rule significantly minimizes or prevents the biological hazards. However, your verification activities did not include verifying your suppliers’ compliance with the Produce Safety Rule or documenting processes or procedures that provide at least the same level of public health protection as required by the Produce Safety Rule.

Specifically, your “FSVP Foreign Supplier Verification Activity(ies) Worksheets” dated July 8, 2021 for enoki mushrooms imported from (b)(4), shipped to you by (b)(4), enoki mushrooms imported from (b)(4), and oyster mushrooms from (b)(4), describe your verification activities as “Safety record review” and the justification for your verification activities as “SAHCODHA Haz (yearly onsight audit).” The records you provided to demonstrate your verification activities for these foods and suppliers include GlobalGAP certificates, HACCP System certificates, a certificate for “Nonpesticides crop,” and testing results for heavy metals in water. However, these records do not indicate whether you verified your suppliers’ compliance with the Produce Safety Rule and do not compare the standards on which the certificates are based to the level of public health protection provided by the Produce Safety Rule.

5. You must ensure that, for each line entry of food product offered for importation into the United States, your name, electronic mail address, and unique facility identifier recognized as acceptable by FDA, identifying you as the importer of the food, are provided electronically when filing entry with U.S. Customs and Border Protection, as required by 21 CFR 1.509(a). As the owner or consignee of food that is being offered for import into the United States, you are the importer (see 21 CFR 1.500). However, the required information was not provided to identify you as the FSVP importer for several shipments of mushrooms you imported, including those in entries AWJ-0222036-1 and AWJ-0210534-9. It is your responsibility to ensure that the required information under 21 CFR 1.509(a) is provided at the time of entry.

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 from the identified foreign suppliers 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 to the violations described above, we offer the following comment:

Your “FSVP Supplier Evaluation Forms” for enoki mushrooms imported from (b)(4), and shipped to you by (b)(4), and enoki mushrooms imported from (b)(4), dated July 8, 2021, indicate that you did not approve your suppliers due to “deficiencies found, Import Alert 99-23 and Import Alert 99-35.” Your action to discontinue use of your foreign suppliers appears to be a corrective action based on a determination you made that the foreign suppliers do 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, if either is applicable, and the implementing regulations, or produce food that is adulterated under section 402 or misbranded under section 403(w) (if applicable), as required under 21 CFR 1.508(a). Note that you must also promptly investigate to determine whether your FSVP is adequate and, when appropriate, modify your FSVP, if, by means other than the verification activities conducted under 21 CFR 1.506, you determine that a foreign supplier of food that you import does not produce 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, or produces food that is adulterated under section 402 or misbranded under section 403(w) (if applicable), as required by 21 CFR 1.508(b).

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 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: Juliane Jung-Lau, Compliance Officer, Division of West Coast Imports, 1201 Harbor Bay Parkway, Alameda, CA 94502, with a copy via electronic mail to [email protected]. If you have any questions regarding this letter, you may contact Ms. Jung-Lau via email at [email protected]. Please reference CMS # 619065 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.

Sincerely,
/S/

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