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.

Kareem Mart Inc.
Garden City, MI

An import company in Michigan is on notice from the FDA for not having FSVPs for a number of imported products, including Hummus with Tahina (Tahini). This inspection and warning letter comes a few months after Kareem Mart Inc. issued a recall of its Kareem Chef brand “Halva” because of potential Salmonella contamination.

In a May 11 warning letter, the FDA described a Nov. 18, 2020, Dec. 21, 2020, and Jan 20-21, 2021, Foreign Supplier Verification Program (FSVP) inspection of FSVP records Kareem Mart Inc. submitted electronically to the FDA. 

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:

  1. As a very small importer, for each food the firm imports, they must obtain written assurance, before importing the food and at least every two years thereafter, that their foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) (if applicable) of the FD&C Act. During the FDA inspection, the firm told FDA investigators they did not have any FSVP documents, including written assurances, for a number of the food products they import, including their Hummus with Tahina (Tahini) and other products imported from (redacted). They told the FDA that they had letters of assurance from their (redacted) located in the (redacted) located in (redacted). However, to the extent they intend to rely on these written assurances, neither of these foreign suppliers included information indicating that the food products they are importing are covered by their written assurances. Further, although the written assurances state that the supplier uses processes and procedures to comply with “the preventive control’s requirements in the PC Human Food Rule” and with “current good manufacturing practice,” they do not include assurances that the supplier is producing the food in compliance with sections 402 and 403(w) (if applicable) of the FD&C Act.
  2. The firm must promptly take appropriate corrective actions if they determine that a foreign supplier of food they import does not produce the food consistent with the assurance provided. The appropriate corrective actions will depend on the circumstances but could include discontinuing use of the foreign supplier until the cause or causes of circumstances have been adequately addressed. The firm must document any corrective actions they take. During FDA inspection, the firm told FDA investigator that they discontinued importing any products containing sesame seeds from Kareem Mart Inc., Syria after receiving the Notice of Action from FDA dated November 6, 2020, indicating that (redacted) products from their (redacted) were found to be adulterated and subject to refusal per 402(a)(1) and 801(a)(3) of the FD&C Act respectively after they tested positive for Salmonella (also see Import Alerts 99-19 and 99-43). The firm also stated they believed that the Salmonella was from the sesame seed ingredient in the products. Although they responded verbally to the investigator, the firm did not document corrective actions taken in response to their determination that the foreign supplier did not produce the food consistent with the assurance provided.

The full warning letter can be viewed here.

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