As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems. The FDA frequently redacts parts of warning letters posted for public view.
Wismettac Asian Foods, Inc.
Santa Fe Springs, CA
An import company in California is on notice from the FDA for not having FSVPs for a number of import violations. The FSVP inspection was initiated as part of a Salmonella Stanley multi-state outbreak investigation.
In an April 29 warning letter, the FDA described a Sept.28-30, Oct. 2, 5-6. 9 and 13 2020, Foreign Supplier Verification Program (FSVP) inspection of FSVP records submitted to the FDA electronically by Wismettac Asain Foods Inc. The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a.
The firm’s significant violations of the FSVP regulation are as follows:
- The firm did not meet the requirements to evaluate their foreign supplier’s performance for the products they import. Specifically, for their foreign supplier of Black Fungus (Kikurage), (redacted), they did not evaluate their foreign supplier’s performance and the risk posed by the food or document their approval of their foreign supplier on the basis of the evaluation.
During FDA inspection the firm provided a Supplier Approval Assessment, dated February 27, 2018, for (redacted). 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.
(Redacted) does not meet the definition of foreign supplier because (redacted) did not manufacture/process or grow the food.
For the actual foreign supplier, (redacted), the FDA acknowledges that they provided a Food Safety HACCP Plan dated July 24, 2020, including a hazard analysis and a Supplier Approval Questionnaire, dated Sept. 28, 2020. However, they did not provide records showing that they conducted the evaluation required or the approval based on the evaluation required. In their response to the FDA 483a, the firm stated they no longer purchase mushroom products from this foreign supplier, and they are not able to conduct a supplier assessment until they complete corrective actions including a root cause analysis, in response to the Salmonella outbreak.
The firm further stated their Shanghai office is working with the supplier and they list steps the supplier is taking to minimize contamination. They provided environmental and product sample analysis from the supplier. The firm indicated if their supplier is not able to take corrective actions, they will consider changing suppliers or will “switch the product from dried fungus product to fully cooked dried fungus (Ready-to-Eat product)”. While the FDA appreciates the steps they have taken, the fact remains they imported Black Fungus (Kikurage), which were found to be the source of an outbreak of foodborne illness, without conducting the required evaluation of their foreign supplier’s performance and the risk posed by the food prior to importation.
Because the firm’s response indicates their ongoing evaluation of this supplier of their Black Fungus (Kikurage), the FDA would like to clarify that they consider their Black Fungus (Kikurage) a ready-to-eat (RTE) food. 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 their Black Fungus (Kikurage), Salmonella would be a known or reasonably foreseeable hazard that may be present in the food and that they should address in their FSVP.
- The firm did not develop, maintain, and follow an FSVP as required. Specifically, they 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 (redacted)
- Seaweed, imported from (redacted)
- Chestnut, imported from (redacted)
- Agar Agar (Gelatin) imported from (redacted)
- Rice flours, imported from (redacted)
- Flavored or Party crackers, imported from (redacted)
- Rice grain snack, imported from (redacted)
- Citrus, mixed jam jelly preserves, imported from (redacted)
The firm’s response to the 483a stated that these foods will be the subject of forthcoming FSVPs. For this latter category, they stated that they planned to develop the FSVPs by November 30th. However, they did not provide documentation that would otherwise allow us to verify their corrections. If they have completed corrections, they may submit documentation of such in response to this letter. Otherwise, the FDA will verify their corrections during the FDA’s next inspection.
- The firm must conduct a hazard analysis to determine whether there are any hazards requiring a control. A hazard means any biological, chemical, or physical agent that is reasonably likely to cause illness or injury. 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. However, during FDA inspection which concluded October 13, 2020, the FDA provided their hazard analysis for Shiitake mushroom from their foreign supplier, (redacted), which did not identify biological hazards, or pathogens, as hazards requiring a control. The firm’s 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 (redacted).” At the (redacted) acceptance processing step, their hazard analysis listed pathogenic bacteria, mold, and parasites as potential biological hazards and states the (redacted) may bring “(redacted) 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 their hazard analysis identifies biological hazards on raw materials, it does not identify them as hazards requiring a control at any step during production.
The FDA acknowledges that in their response to the FDA 483a, the firm submitted a revised HACCP Plan, including a revised hazard analysis, from their foreign supplier for their Shiitake mushroom from manufacturer (redacted). However, they did not document their review and assessment of the revised hazard analysis. The FDA acknowledges that they also stated that they stopped importing Shitake mushrooms from (redacted) pending their review of the revised HACCP plan and a report of an audit conducted by (redacted) on 10/26/2020. However, the fact remains that they imported the product without complying with FSVP requirements.
The full warning letter can be viewed here.
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