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October 29, 2021

WARNING LETTER

Re: CMS #616923

Dear Mr. Shin:

On June 8, 2021 through June 10, 2021, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection of Marquis Worldwide Specialty, Inc., located at 883 S, City of Industry, CA 91748-1028. 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.

Our inspection was initiated in response to the recent recall event associated with mushroom products imported by you from your foreign suppliers. Specifically, you were notified by the California Department of Public Health (CDPH) that retail samples of Organic Enoki Mushroom products, imported from your foreign supplier, (b)(4), tested positive for Listeria monocytogenes. These analytical findings resulted in you conducting a voluntary recall of the imported Organic Enoki Mushroom products on May 28, 2021.

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: organic enoki mushroom imported from (b)(4) in (b)(4) and organic king oyster mushroom imported from (b)(4) in (b)(4). Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.

At the conclusion of the FSVP inspection, our investigator provided you with a Form FDA 483a FSVP Observations. We acknowledge receipt of your responses dated June 28, 2021, August 16, 2021, and September 2, 2021, and we address your responses below.

Your significant violations are as follows:

1. You did not develop, maintain, and follow an FSVP that provides adequate assurances that your foreign supplier is producing the food in compliance with processes and procedures that provide the required level of public health protection as those required under section 418 (regarding hazard analysis and risk-based preventive controls for certain foods) or 419 (regarding standards for produce safety), if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 (regarding adulteration) and 403(w) (if applicable) (regarding misbranding with respect to labeling for the presence of major food allergens) of the Federal Food, Drug, and Cosmetic Act., as required by 21 CFR 1.502(a). Specifically, you did not develop, maintain, and follow an FSVP that provides adequate assurances that the food products from your foreign suppliers, which are raw agricultural commodities covered under 21 CFR 112 Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (the Produce Safety Rule), were produced in compliance with the FD&C Act, sections 419 and 402, for each of the following foods:

• Organic enoki mushrooms, from your foreign supplier, (b)(4) in (b)(4), and
• Organic oyster mushrooms from your foreign supplier, (b)(4) in (b)(4).

Enoki mushrooms and king oyster mushrooms are “covered produce” as defined in 21 CFR 112.3, and therefore must comply with the Food Safety Modernization Act (FSMA) Produce Safety Rule, yet none of the records you provided show that the hazard analyses of your foreign suppliers considered this regulation. Further, your evaluation and approval of your foreign suppliers did not consider whether the suppliers were producing the food in accordance with the Produce Safety Rule.

For example, your June 28, 2021 response to FDA’s Form 483a included the hazard analysis for enoki mushrooms from your foreign supplier (b)(4) which does not consider the Produce Safety rule, does not cover the growing and harvesting processes, and does not identify Listeria monocytogenes as a biological hazard in need of a control. Similarly, the hazard analysis you submitted for king oyster mushrooms from your foreign supplier (b)(4) also does not consider the Produce Safety Rule, does not cover growing and harvesting processes, and does not identify Listeria monocytogenes as a biological hazard in need of a control. 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). Your Foreign Supplier Verification Program Evaluation Procedure you submitted on June 28, 2021 states that you will evaluate each imported foreign food for biological hazards that are reasonably likely to occur and that you may rely on an accredited third-party testing facility to conduct a hazard analysis and that you will review and assess the relevant documentation. We are unable to evaluate the adequacy of your responses because you did not include any records in your responses documenting that you had evaluated, reviewed, and assessed your foreign suppliers for compliance with the Produce Safety Rule. 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).

2. You did not modify your FSVP or document changes to your FSVP as a result of the prompt investigation you were required to undertake when you became aware 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). Specifically, in addition to the retail samples collected by CDPH, FDA collected samples on June 8, 2021 and July 1, 2021 of enoki mushrooms that you imported from your foreign supplier, (b)(4). Your enoki mushrooms were found to be contaminated with Listeria monocytogenes and found adulterated per section 402. In response to FDA sample findings, on July 14, 2021, your foreign supplier (b)(4) was placed on the Red List of Import Alert #99-23, Detention Without Physical Examination of Produce Due to Contamination with Human Pathogens.

You submitted responses on dated June 28, 2021, August 16, 2021, and September 2, 2021, which describe your completed and planned corrective actions, including conducting training for employees on FSVP and the Produce Safety Rule and revising your FSVP documents for imported mushroom products. However, you did not provide records showing you implemented any revised FSVP, as required per 21 CFR 1.505(c), 21 CFR 1.506, and 21 CFR 1.508(b). Your June 28, 2021, response stated that based on your re-evaluation, you will discontinue importing enoki mushrooms from your supplier, (b)(4) until they conduct a root cause analysis and implement corrective actions. Your August 16, 2021 and September 2, 2021, responses stated that (b)(4) conducted a root cause analysis, which ultimately identified the PET covers as the possible route of contamination. Your suppliers indicated that they have cleaned, sanitized, and conducted environmental swabbing. In response to your suppliers’ corrective actions, you state that you will re-evaluate and conduct an onsite/virtual audit, however, details were not provided on the outcomes of your evaluation.

Your August 16, 2021 response states that all FSVP documents for all imported products subject to the Produce Safety Rule have been revised, but, as part of your corrective actions, you did not provide any revised or updated FSVPs that provide adequate assurances that your foreign suppliers are 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 and section 402 of the FD&C Act, in accordance with 21 CFR 1.502(a) and 21 CFR 1.508(b). You have not provided documentation that your FSVPs were revised to evaluate your foreign suppliers hazard analyses with respect to the growing or harvesting conditions for the foods they produce or account for Listeria monocytogenes as a biological hazard reasonably likely to occur or procedures for how this hazard will be controlled.

Your September 2, 2021 response titled “Final Complete Response to FDA 483(a) Observations” also did not contain any revised FSVPs. Your response states that “preventative actions will be followed to ensure food safety compliance in future production” and that “re-evaluation . . . of . . . [your] foreign suppliers . . .” will occur, but no documentation was included to demonstrate that this was actually completed. Therefore, we are unable to determine the adequacy of your responses.

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.

You should take prompt action to address the above violations. If you do not promptly address 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 the enoki mushroom imported from your foreign supplier (b)(4) and oyster mushrooms imported from your foreign supplier (b)(4). We may place the foods you import from the identified foreign suppliers on detention without physical examination (DWPE) when you import the products. 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.

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 address these violations. You should include in your response documentation and information that will assist us in evaluating your response, (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 addressing these violations within 15 days, you should explain the reason for your delay and state the time within which you will do so.

Please send your reply to Food and Drug Administration, Attention: Mr. David Serrano, Compliance Officer, One World Trade Center, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact Mr. Serrano via email at david.serrano@fda.hhs.gov. Please reference CMS #616923 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
Program Division Director
Division of West Coast Imports