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 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 whereby they may have been rendered injurious to health.
The FDA investigator observed the following significant violations:
- The firm must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points; “However, your firm’s HACCP plan entitled “HACCP plan for Fresh Filleting Non Scrombroid Fish Products – (Raw Consumption)” does not list a critical control point for controlling the food safety hazard of parasites”;
- The firm must implement the monitoring procedures and frequency that they have listed in their HACCP plan; “Specifically, during the inspection you told the investigator that the employee responsible for monitoring the cooler did not have access to the electronic database used to record the cooler temperatures and therefore could not monitor the continuous temperature critical limit.”;
- During inspection, the firm stated that they routinely process seafood products on Saturday, however, HACCP monitoring activities are only conducted Monday through Friday, and the firm is required to implement monitoring procedures whenever they process ready-to-eat and vacuum-packaged seafood;
- The firm did not record monitoring observations at the receiving critical control point (CCP #1) to control pathogen growth and toxin formation listed in their HACCP plan entitled “HACCP plan for Fresh Filleting Non Scrombroid Fish Products – (Raw Consumption).”; and
- The firm did not maintain sanitation monitoring records every day seafood processing is conducted and during every processing shift.
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.”
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 whereby they may have become contaminated with filth, or whereby 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:
- The firm did not conduct operations under conditions and controls necessary to minimize the potential for contamination of food; “On March 4, 2019 the investigator observed a fly-like insect in an open container of sugar. You are responsible for ensuring ingredients are properly stored to protect against contamination.”;
- The firm did not provide hand-washing facilities designed to ensure that an employee’s hands are not a source of contamination of food, food-contact surfaces, or food-packaging materials, by providing facilities that are adequate, convenient and furnishing running water at a suitable temperature; “The investigator also observed an employee handle ready-to-eat pumpkin mushroom noodles after touching multiple non-food contact surfaces without changing their gloves and/or washing their hands.”;
- The firm did not clean and sanitize utensils and equipment in a manner that protects against contamination of food, food contact surfaces, or food packaging materials;
- The firm did not clean non-food contact surfaces of equipment used in the operation of a food plant in a manner and as frequently as necessary to protect against allergen cross-contact and against contamination of food, food-contact surfaces, and food-packaging materials;
- The FDA noted a “repeat observation from the previous inspection dated December 12-13 and 19, 2017,” stating that the firm’s response to this observation is inadequate;
- The firm did not have a qualified individual engaged in manufacturing, processing, packing, or holding food who has received training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, as appropriate to the food, the facility and the individual’s assigned duties;
- The firm’s fish with ginger sauce meal product is misbranded in that the finished product fails to bear labeling that declares the major food allergen, fish;
- The product also fails to bear labeling with the common or usual name of the food; “You manufacture the meal for sale to an airline caterer, who subsequently resells the product to airlines. However, the meals fail to bear labeling with a statement of identity.” and
- The product also fails to bear labeling that lists all the common or usual names of each ingredient used, and the net quantity of contents.
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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