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The Food and Drug Administration recently sent warning letters to a tahini importer in Florida in relation to an outbreak, and a seafood processor and airline caterer in California, because inspectors found significant violations of U.S. food safety laws at their operations.
Businesses have 15 days to respond in writing to the FDA after receiving a warning letter. If they don’t correct the violations, the FDA can take action up to and including shutting down operations.
Min Jiang Food Store, Inc., doing business as Koi Koi Trading — Montebello, CA
Min Jiang Food Store Inc., doing business as Koi Koi Trading in Montebello, CA, is on notice from the FDA because of significant deviations from the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, and the Current Good Manufacturing Practice regulation for foods under the Federal Food, Drug, and Cosmetic Act (the Act). The firm processes fish products, which must have a HACCP plan that complies with The Act.
Staff from the Food and Drug Administration inspected the firm’s Montebello facility on April 23 and 26, and rendered the firm’s fresh filleted salmon for raw consumption and refrigerated vacuumed packaged surimi seafood products adulterated, in that they have been prepared, packed, or held under insanitary conditions wherby they may have been rendered injurious to health.
The FDA investigator observed the following significant violations:
FDA officials warned that they may pursue additional enforcement actions if the firm does not promptly correct these violations.
“You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by FDA without further notice, including, without limitation, seizure and injunction.”
T&W LLC — Millbrae, CA
In an Aug. 2 warning letter to company owner Wendy O.P. Fu the FDA described violations observed during inspections March 4-6, and on March 8 at the firm’s airline catering facility in Millbrae, CA. According to the warning letter, the investigators observed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods.
The FDA acknowledged receipt of April 1 email response from the firm, addressing FDA investigator’s observations of concern and included various corrective actions already taken and other corrections scheduled to be completed by your firm.
However, based on FDA’s inspectional findings and assessment of the email response, the prepared meals the firm manufactures are adulterated in that they are prepared, packed or held under insanitary conditions wherby they may have become contaminated with filth, or wherby they may have been rendered injurious to health. Additionally, FDA conducted a review of the labeling of the firm’s prepared meals as inflight meals and found significant violations of the labeling regulations for foods causing the firm’s meals to be misbranded.
The following significant violations are noted regarding the adulterated and misbranded foods:
Brodt Zenatti Holdings LLC — Jupiter, FL
As recently reported by Food Safety News, an importer in Jupiter, FL is on notice from the FDA for failing to take required steps to assure that they are in compliance with Foreign Supplier Verification Program (FSVP) of the Federal Food, Drug and Cosmetic Act (FD&C Act) for the tahini products the firm brings into the U.S.
“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.”
Staff from the Food and Drug Administration inspected the Jupiter, FL location of Brodt Zenatti Holdings LLC on May 17, and discovered the “significant violation,” according to an July 30 warning letter made public in recent days by the FDA.
“During our inspection, we found that you are not in compliance with the requirements of 21 CFR Part 1 subpart L for your tahini imported from Karawan Tahini and Halva, located in the West Bank (i.e., Karawan),” and, “Because of these significant violations, you are not in compliance with section 805 of the FD&C Act,” according to the letter sent to Owner Avi Snati by Ruth P. Dixon, Program Division Director of the Division of Southeast imports.
According to the warning letter, the inspection was initiated as part of a Salmonella Concord multi-state outbreak investigation; “During the investigation, epidemiologic and traceback analyses of records and information supplied by firms along the distribution chain identified Karawan brand tahini as the likely source of the outbreak.” The FDA said Salmonella Concord was also isolated from a sample of Karawan brand tahini analyzed by New York City Department of Health during the course of the investigation. Karawan brand tahini is imported by Brodt Zenatti Holdings LLC.
At the conclusion of the FSVP inspection, FDA investigators provided the firm with Form FDA 483a, FSVP observations; “We acknowledge you have conducted a voluntary recall of Karawan brand and SoCo brand of tahini, and you verbally committed to cease importing the product.” However, to date, the FDA has not received the firm’s response to the Form FDA 483a for their FSVP violations, and their voluntary recall does not address the FSVP violations.
The FDA noted the following significant deviation:
• You did not develop an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1 subpart L. Specifically, your firm did not develop an FSVP for sesame paste tahini manufactured by Karawan Tahini and Halva in the West Bank.
“We may take further action if you do not promptly correct these violations. For instance, we may take further action to refuse admission of your imported fish or fishery products, … including placing them on detention without physical examination, seize your product(s) and/or enjoin your firm from further violating the Act.”
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