FDA Inspection Leads to an Issuance of a Warning Letter Kareem Mart Inc.
FDA – A news report on foodsafetynews.com states that the United States Food and Drug Administration has issued warning letters to entities that are under the agency’s jurisdiction. This process is part of the FDA’s enforcement activities. The inspection and warning letters are following Kareem Mart Inc’s recall of its Kareem Chef brand “Halva.” The company’s products are potentially contaminated with Salmonella.
Kareem Mart Inc is on notice from the FDA for not participating in the mandated Foreign Supplier Verification Program (FSVP) as required for several of its imported products, such as Hummus with Tahina (Tahini). A few of the FDA’s letters were not available for public view until weeks or months after the letters were sent. Business owners are required to respond to the FDA’s warning letters within fifteen days. The FDA warning letters are typically not sent until a company has been provided with several months to years to correct issues. The FDA often redacts portions of the warning letters that are released to the public.
In May 11, 2021, the FDA sent a warning letter to Kareem Mart Inc describing the “November 18, 2020, December 21, 2020, and Jan 20-21, 2021, Foreign Supplier Verification Program (FSVP) inspection of FSVP records Kareem Mart Inc. submitted electronically to the FDA.”
According to the FDA’s inspection results, it was ascertained that the company was not complying with the FSVP regulations, and the FDA issued an FDA Form 483a. The company’s substantial violations of the FSVP regulations.
The small food importer is required by law to obtain written assurance prior to importing food into the United States at least every two years after the initial assurance. The importer must receive assurances from its foreign supplier that the food it is producing out of the U.S. is in compliance with procedures and processes in sections 402 and 403(w) (if applicable) of the Federal Food, Drug, and Cosmetic Act. According to the FDA warning letters, as the FDA performed its inspection, Kareem Mart Inc told the FDA investigators it didn’t have any FSVP documents or written assurances for several of the food products the company is importing, including its “Hummus with Tahina (Tahini),” and several other products the company imports. The FDA redacted the additional products from the public copy of the warning letters to Kareem Mart Inc.
Kareem Mart is required to take swift and “appropriate corrective actions” when it determines that a foreign food supplier did not produce the food products consistent with the assurance furnished. Even though Kareem Mart responded verbally to the investigator, the company did not document the corrective actions that the importer took to determine if the foreign food supplier didn’t produce the food that is consistent with the assurance provided.
The full FDA warning letter may be viewed here.
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