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.
Krishiv Foods LLC
An import company in Illinois is on notice from the FDA for not having FSVPs for a number of imported food products.
In an April 25, 2023, warning letter, the FDA described a Nov. 30 through Dec. 13, 2022, Foreign Supplier Verification Program (FSVP) inspection of Krishiv Foods,LLC in Elk Grove Village, Illinois.
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 significant violations are as follows:
1. The firm must conduct a hazard analysis for each type of food they import to determine whether there are any hazards requiring a control. Although they may meet this requirement by reviewing and assessing the hazard analysis conducted by another entity using a qualified individual, they must document their review and assessment of that hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual. During the inspection, the firm provided copies of their foreign supplier hazard analysis for whole nutmeg, moong dal, and whole mustard seeds imported from (redacted), located in (redacted). Although they stated in an email dated Dec. 8, 2022, that they “review and evaluate all hazard analysis (redacted) or sooner as needed,” they did not provide documentation that they have reviewed and assessed their foreign supplier’s hazard analyses.
2. The firm did not meet the requirement to evaluate their foreign supplier’s performance and the risk posed by the food, and to approve their foreign supplier on the basis of this evaluation. Specifically, during the inspection, they stated in an email dated Dec. 8, 2022, that they chose named foreign suppliers “based on their market reputation and demand of their products by consumers.” They further stated that their “foreign suppliers are FDA registered and hold various certificates, which makes them trustworthy. They are also focused highly on quality of products and take all feedback very seriously.” However, for their foreign supplier (redacted), located in (redacted), they did not document their evaluation of the foreign supplier’s performance and the risk posed by the food, or document their approval of the foreign supplier.
3. The firm did not meet the requirement to conduct (and document) or obtain documentation of one or more of the supplier verification activities for each foreign supplier before importing the food and periodically thereafter. Specifically, they did not conduct (and document) or obtain documentation of one or more such supplier verification activities for their foreign supplier (redacted), located in (redacted), before importing whole nutmeg, moong dal, and whole mustard seeds. During the inspection, they stated in an email dated Dec. 8, 2022: “we (redacted) audit each shipment and (redacted) check items sent by foreign suppliers. We also follow the food safety plan to make sure that these items are ready to be consumed by consumers. Items that are on import alert are lab tested to assure the quality.” However, the firm did not provide documentation of verification activities for moong dal and whole mustard seeds. They responded to the FDA investigator’s request for verification records by providing documents sent to U.S. Customs at the time of import entry and asserted that testing is done prior to importation and was reported on one of the documents they provided titled, “Quality Evaluation Laboratory Spices Board Test Report.” However, as the FDA investigator explained, this report did not include testing results for the relevant foods, specifically, nutmeg, moong dal, and mustard seeds. For the whole nutmeg imported from (redacted), located in (redacted), which is listed on Import Alert #99-19, “Detention Without Physical Examination of Food Products Due to the Presence of Salmonella,” they provided a laboratory report from (redacted) with sample results for Salmonella. However, this laboratory report did not include test results for all hazards associated with the whole nutmeg and they did not provide documentation of any other verification activities.
The full warning letter can be viewed here.
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