- Delivery Method:
- United Parcel Service
- Food & Beverages
Recipient NameHiroshi Matsuo
Recipient TitleSenior Manager of Food Safety Department
- Wismettac Asian Foods, Inc.
13409 Orden Dr.
Santa Fe Springs, CA 90670-6336
- Issuing Office:
- Division of West Coast Imports
April 29, 2021
Re: CMS #611877
Dear Mr. Hiroshi Matsuo:
On September 28-30, October 2, 5-6, 9 and 13, 2020, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of FSVP records that you submitted to FDA electronically. We also conducted inspections on March 6, 2020 and August 30, 2017. These inspections were 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 under 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 most recent FSVP inspection was initiated as part of a Salmonella Stanley multi-state outbreak investigation. During the investigation, epidemiologic and traceback analyses of records identified Shirakiku brand Black Fungus (Kikurage), also known as wood ear mushroom, distributed by your firm as the likely suspect of the outbreak. Information uncovered during our inspection regarding the facilities who conduct processing of your Black Fungus (Kikurage) identified your supplier as (b)(4). Additionally, the California Department of Public Health (CDPH) collected and analyzed samples of unopened packages of your Black Fungus (Kikurage), confirming them to contain Salmonella Stanley. FDA analysis of whole-genome sequencing (WGS) of the isolates from the CDPH samples determined the isolates matched the outbreak strain and likely came from the same source. We acknowledge you initiated a voluntary recall of your Black Fungus (Kikurage).
During the inspection, we found that you were not in compliance with the requirements of 21 CFR part 1 subpart L for your Black Fungus (Kikurage) manufactured by (b)(4); your Shiitake mushroom sliced, manufactured by (b)(4); and the imported products on “List of foods with no FSVP – Wismettac Asian Foods Inc. 10-12-2020.”. 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, which indicates you have not complied with the FSVP regulation.
We acknowledge receipt of your emailed response dated November 3, 2020 which included a cover letter addressing the observations on the FDA 483a, and several supporting documents related to your FSVPs, including product and environmental swab sample results from the drying and packing facility for your Black Fungus (Kikurage), the “List of foods with no FSVP - Wismettac Asian Foods Inc. 10-12-2020” with added notations, an updated HACCP plan from the packing facility for your Shitake mushrooms, a copy of your supplier approval program, and an updated supplier approval assessment sheet. We address your response below.
Your significant violations of the FSVP regulation are as follows:
1. You did not meet the requirements to evaluate your foreign supplier’s performance in accordance with 21 CFR 1.505 for the products you import. Specifically, for your foreign supplier of Black Fungus (Kikurage), (b)(4), you did not evaluate your foreign supplier’s performance and the risk posed by the food (as required by 21 CFR 1.505(a)) or document your approval of your foreign supplier on the basis of the evaluation (as required by 21 CFR 1.505(b)).
During our inspection you provided a Supplier Approval Assessment, dated February 27, 2018, for (b)(4). However, this entity is not the foreign supplier of Black Fungus (Kikurage). Foreign supplier means, for an article of food, the establishment that manufactures/processes the food, raises the animal, or grows the food that is exported to the United States without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labeling or any similar activity of a de minimis nature (21 CFR 1.500).
(b)(4) does not meet the definition of foreign supplier because (b)(4) did not manufacture/process or grow the food.
For the actual foreign supplier, (b)(4), we acknowledge that you provided a Food Safety HACCP Plan dated July 24, 2020, including a hazard analysis and a Supplier Approval Questionnaire, dated September 28, 2020. However, you did not provide records showing that you conducted the evaluation required by 21 CFR 1.505(a) or the approval based on the evaluation required by 21 CFR 1.505(b). In your response to the FDA 483a, you stated you no longer purchase mushroom products from this foreign supplier, and you are not able to conduct a supplier assessment until they complete corrective actions including a root cause analysis, in response to the Salmonella outbreak. You further stated your Shanghai office is working with the supplier and you list steps the supplier is taking to minimize contamination. You provided environmental and product sample analysis from the supplier. You indicated if your supplier is not able to take corrective actions, you will consider changing suppliers or will “switch the product from dried fungus product to fully cooked dried fungus (Ready-to-Eat product)”. While we appreciate the steps you have taken, the fact remains you imported Black Fungus (Kikurage), which were found to be the source of an outbreak of foodborne illness, without conducting the required evaluation of your foreign supplier’s performance and the risk posed by the food prior to importation.
Because your response indicates your ongoing evaluation of this supplier of your Black Fungus (Kikurage), we would like to clarify that we consider your Black Fungus (Kikurage) a ready-to-eat (RTE) food in accordance with 21 CFR 117.3. It is reasonably foreseeable that the food will be eaten without further processing that would significantly minimize biological hazards. Additionally, in light of the Salmonella findings in samples of your Black Fungus (Kikurage), Salmonella would be a known or reasonably foreseeable hazard that may be present in the food and that you should address in your FSVP.
2. 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 the following products on the “List of foods with no FSVP – Wismettac Asian Foods Inc. 10-12-2020:”
- Eggplant, imported from (b)(4)
- Seaweed, imported from (b)(4)
- Chestnut, imported from (b)(4)
- Agar Agar (Gelatin) imported from (b)(4)
- Rice flours, imported from (b)(4)
- Flavored or Party crackers, imported from (b)(4)
- Rice grain snack, imported from (b)(4)
- Citrus, mixed jam jelly preserves, imported from (b)(4)
Your response to the 483a stated that these foods will be the subject of forthcoming FSVPs. For this latter category, you stated that you planned to develop the FSVPs by November 30th. However, you did not provide documentation that would otherwise allow us to verify your corrections. If you have completed corrections, you may submit documentation of such in response to this letter. Otherwise, we will verify your corrections during our next inspection.
3. You must conduct a hazard analysis to determine whether there are any hazards requiring a control (21 CFR 1.504(a)). A hazard means any biological, chemical, or physical agent that is reasonably likely to cause illness or injury (21 CFR 1.500). A hazard requiring a control means a known or reasonably foreseeable hazard for which a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would, based on the outcome of a hazard analysis (which includes an assessment of the probability that the hazard will occur in the absence of controls or measures and the severity of the illness or injury if the hazard were to occur), establish one or more controls or measures to significantly minimize or prevent the hazard in a food and components to manage those controls or measures (such as monitoring, corrections or corrective actions, verification, and records) as appropriate to the food, the facility, and the nature of the control or measure and its role in the facility’s food safety system (21 CFR 1.500). However, during our inspection which concluded October 13, 2020, you provided your hazard analysis for Shiitake mushroom from your foreign supplier, (b)(4), which did not identify biological hazards, or pathogens, as hazards requiring a control. Your evaluation of the hazard analysis (on form “Supplier Approval Assessment Sheet”) states, “This product is not Ready to Eat food. Biological hazard is controlled by (b)(4).” At the (b)(4) acceptance processing step, your hazard analysis listed pathogenic bacteria, mold, and parasites as potential biological hazards and states the (b)(4) may bring “(b)(4) bacteria or pollution in the storage and transportation due to insects, animals, and environmental pathogens.” It has been demonstrated that pathogens, including Salmonella, can survive and persist for extended periods of time in low moisture foods. Further studies demonstrate that microorganisms can survive on dried mushrooms. However, the hazard analysis determines that these are not significant hazards. Although your hazard analysis identifies biological hazards on raw materials, it does not identify them as hazards requiring a control at any step during production.
We acknowledge that in your response to the FDA 483a, you submitted a revised HACCP Plan, including a revised hazard analysis, from your foreign supplier for your Shiitake mushroom from manufacturer (b)(4). However, you did not document your review and assessment of the revised hazard analysis. We acknowledge that you also stated that you stopped importing Shitake mushrooms from (b)(4) pending your review of the revised HACCP plan and a report of an audit conducted by (b)(4) on 10/26/2020. However, the fact remains that you imported the product without complying with FSVP requirements.
This letter is 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. You should take prompt action to correct the above violations. Failure to adequately address this matter may result in 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 food that you import for which you do not have an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation, including placing the food from your identified foreign suppliers on detention without physical examination (DWPE) when you import the products. In addition, Black Fungus (Kikurage) is currently subject to DWPE per import alert 99-19 and 99-43. 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 to the above violations, we also have the following comments: In your response to the FDA 483a observation regarding your hazard analysis for Shitake mushrooms, submitted November 3, 2020, you stated you stopped importing your Shitake mushroom manufactured by (b)(4) pending your review of the revised HACCP plan and the (b)(4) report of an audit they conducted on 10/26/2020. To the extent that these steps are intended to comply with the requirements for corrective actions under 21 CFR 1.508, we note that the requirements for corrective actions are that importers must take appropriate corrective actions if they determine that a foreign supplier of a food they import does not produce the food in compliance with the relevant food safety requirements (21 CFR 1.508(a)). 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 (21 CFR 1.508(a)). 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 (21 CFR 1.508(a)). You must document any such corrective actions taken in accordance with section 1.508 (21 CFR 1.508(a)).
In addition, we note that you must establish and follow written procedures to ensure that you import foods only from foreign suppliers you have approved, and you must document your use of these procedures (21 CFR 1.506(a)(1)). Although your response to the 483a stated that you have written procedures to ensure you import foods only from approved foreign suppliers and you provided a copy of these procedures (“Attachment-7 WAF-M-010 Supplier Approval Program 05-18-2020”), we note that you are still required to follow and document your use of these procedures.
Further, we note that under 21 CFR 1.506(d)(2), when a hazard in a food will be controlled by the foreign supplier and is one for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals, you must conduct or obtain documentation of an onsite audit of the foreign supplier before initially importing the food and at least annually thereafter, unless you make an adequate written determination that, instead of such initial and annual onsite auditing, other supplier verification activities and/or less frequent onsite auditing are appropriate to provide adequate assurances that the foreign supplier is producing the food in accordance with the relevant food safety standards. You provided a copy of your updated Supplier Approval Assessment Sheet which indicates in the Verification Procedures section the frequency of your verification activities as every (b)(4). This is also indicated in your Supplier Approval Program under Verification Frequency. Please note hat under 21 CFR 1.506(d)(2), it is necessary to document the basis for conducting verification activities at a less-than-annual frequency for the hazards for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals.
Please notify FDA 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 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, or that you have complied with FDA regulations, 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: Debbie Giang, 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 Debbie Giang via phone at (562) 256-9235 or via email at firstname.lastname@example.org. Please reference CMS #611877 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.
Lawton W. Lum
Acting Program Division Director
Division of West Coast Imports