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November 3, 2021

WARNING LETTER

Re: CMS #616099

Dear Mr. Choe:

On June 15, 2021, the Food and Drug Administration conducted a Foreign Supplier Verification Programs (FSVP) inspection of Rainfield Marketing Group, Inc. located at 3305 Bandini Blvd, 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 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 a finding of Listeria monocytogenes in a sample of enoki mushrooms from (b)(4) in Korea, collected by California Department of Public Health (CDPH), and imported by your company. We acknowledge you initiated a voluntary recall of your enoki mushrooms. On July 21, 2021, enoki mushrooms from (b)(4) were placed on Import Alert # 99-21 Detention Without Physical Exam of Produce Due to Contamination With Human Pathogens.

During the inspection, we found that you were not in compliance with the requirements of 21 CFR part 1, subpart L for the following foods you import: enoki mushroom imported from (b)(4) located in Korea, king oyster mushroom imported from (b)(4) located in Korea, and spinach imported from (b)(4) located in (b)(4). Your firm did not have FSVPs 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 July 2, 2021, which you described as “Corrective Action for the FDA FSVP inspection…”. We evaluated your response as it relates to your enoki mushroom imported from (b)(4) located in Korea, your king oyster mushroom imported from (b)(4) located in Korea, and your spinach imported from (b)(4) located in (b)(4) but found it inadequate because you did not include all of the necessary supporting documentation, as discussed further below.

You stated you developed FSVPs for the foods that you import and provided procedures and records for those foods, including the evaluation and verification activities for the foreign suppliers for enoki mushroom, king oyster mushroom, and spinach, in addition to other products that were not covered during our inspection. You attached several documents to your response, including documents labeled: “FSVP SOP, Enoki mushroom, Grape, King Oyster Mushroom, Rainfield Marketing Product List, Spinach and Strawberry.” The FSVP SOP included a food safety plan, Hazard Analysis, Risk Evaluation for foreign supplier, Supplier Verification Plan and Record, Reevaluation Program, Allergen Program, and Product Recall Program. You submitted documents titled, “Hazard Analysis” for each of the foods, however these documents lack detailed analysis of the hazards unique to each food and how those hazards will be controlled.

Your response further stated that, based on your evaluation of your suppliers, you discontinued importing from two suppliers of other foods that were not covered during our inspection. You also stated that you stopped importing enoki mushroom due to the recent recall, until corrective actions are made by the supplier, and an onsite audit gives you confidence that future incidents will be prevented. The activities you described involving re-evaluation of your suppliers and your determination to stop importing from them are considered corrective actions, pursuant to 21 CFR 1.508. You are required to document any corrective actions you take in accordance with 21 CFR 1.508(a).

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 stated that you did not develop an FSVP for any foods that you import, including:
• Perilla leaves imported from your foreign supplier (b)(4) located in (b)(4)
• Strawberries imported from your foreign supplier (b)(4) located in (b)(4)
• Strawberries imported from your foreign supplier (b)(4) located in (b)(4)
• Strawberries imported from your foreign supplier (b)(4) located in (b)(4)
• Garlic bulb imported from your foreign supplier (b)(4) located in (b)(4)
• Grapes imported from your foreign supplier (b)(4) located in (b)(4)
• Cilantro imported from your foreign supplier (b)(4) located in (b)(4)

2. Your onsite audit of your foreign suppliers did not include the required verification activities. Specifically, your onsite audit did not consider the applicable food safety regulation and a review of the foreign supplier’s written food safety plan, if any, and its implementation, for the hazard being controlled, as required by 21 CFR 1.506(e)(1)(i)(B). For your foreign suppliers, (b)(4) Korea for enoki mushroom, (b)(4) Korea for king oyster mushroom, and (b)(4) for spinach, your verification activities 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).

Enoki mushrooms, king oyster mushrooms, and spinach are “covered produce” as defined in 21 CFR 112.3, and therefore must comply with FDA’s Standards for Growing, Harvesting, Packing and Holding of Produce for Human Consumption (Food Safety Modernization Act (FSMA) Produce Safety Rule) regulation. None of the records you provided show your foreign suppliers considered this regulation or processes and procedures that provide at least the same level of public health protection as the applicable food safety regulation.

In your response to FDA’s Form 483, you submitted a document titled “Corrective Action for the FDA FSVP inspection” wherein, you stated that you have discontinued importation from two suppliers of products not covered by this current inspection, and that you will discontinue importing from your enoki mushroom supplier. You further stated that all your remaining suppliers have GAP/Primus certification, “which is similar to FDA Produce Safety Rule.” Additionally, you submitted supplier evaluation records, including your Supplier Evaluation Forms and supporting documentation that indicate the following:

• Your foreign supplier of enoki mushrooms, (b)(4) was evaluated for compliance with Korea Good Agricultural Practice (GAP) and ISO22000 and conditionally approved on June 29, 2021. You stated an “onsite audit will be followed soon.” You submitted a GAP certificate for (b)(4) for enoki mushroom. However, you did not provide documentation of an onsite audit or documentation that the foreign supplier’s processes and procedures provided the same level of public health protection as the as the produce safety regulation.
• Your foreign supplier of king oyster mushrooms, (b)(4) was evaluated for compliance with Korean GAP and was approved on June 29, 2021. You submitted a document purporting to be a GAP certificate for (b)(4) for king oyster mushrooms.
However, the certificate is not in English, and no further documentation was provided to demonstrate that an onsite audit occurred that considered the produce safety regulation.
• Your foreign supplier of spinach, (b)(4) was evaluated based on a questionnaire in which they stated they implemented Good Manufacturing Practice and GAP in accordance with the “Food Safety Rule,” are audited by Primus GFS, and was approved on June 17, 2021. You submitted documents detailing the results of an onsite audit by Primus GFS, dated February 18, 2021, for (b)(4) for spinach. The documents do not mention the produce safety regulation or document that the foreign supplier’s processes and procedures provide the same level of public health protection as the produce safety regulation.

An importer may import food consistent with the FSVP regulation even if their foreign supplier uses processes or procedures that vary in some way from the processes and procedures required under the applicable requirements in these regulations, provided that the importer follows an FSVP that provides adequate assurance that the processes and procedures that the supplier uses provide the same level of public health protection as those required under the specified FDA requirement. However, you did not provide details of your evaluation that concluded that your supplier’s processes and procedures provided the same level of public health protection as the produce safety regulation, nor did you provide data or information to allow the FDA to conduct such an evaluation.

For more information on consideration of whether processes and procedures used in lieu of an FDA food safety regulation provide the same level of public health protection, see FDA’s Draft Guidance for Industry: Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR part 112 or the Preventive Controls Requirements in part 117 or 507, which you may find at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-considerations-determining-whether-measure-provides-same-level-public-health.

It is your responsibility to evaluate and verify your suppliers of covered produce based on compliance with the Produce Safety Rule, in accordance with 21 CFR 1.505(a)(1)(iii)(B).

3. You did not retain documentation of each sampling and testing of a food, including identification of the food tested (including lot number, as appropriate), the number of samples tested, the test(s) conducted (including the analytical method(s) used), the date(s) on which the test(s) were conducted and the date of the report of the testing, the results of the testing, any corrective actions taken in response to detection of hazards, information identifying the laboratory conducting the testing, and documentation that the testing was conducted by a qualified individual, as required by 1.506(e)(1)(ii). Specifically, you did not retain documentation of the number of samples tested, of the test(s) conducted, and that the testing was conducted by a qualified individual, in accordance with your written procedure per 1.506(b), titled your “Supplier Verification Plan and Record” dated June 28, 2021. You submitted certificates of laboratory testing for enoki mushrooms dated March 31, 2021 for receipt no. (b)(4) and certificates of laboratory testing dated April 13,2021 for receipt no. (b)(4) as documentation of your verification activity for (b)(4). However, those certificates of laboratory testing did not identify the number of samples tested, the test method(s), or the qualification of the individual that conducted the testing.

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)).

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 will assist us in evaluating your corrections, (e.g., documentation of changes you made, such as a copy of your revised FSVP and 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 response to Food and Drug Administration, Attention: Lydia Chan, Compliance Officer, 1201 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding this letter, you may contact Lydia Chan via email at [email protected]. Please reference CMS #616099 on any documents or records you provide to us and on the subject line of any email or other correspondence you send to us.

Sincerely,
/S/

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