April 27, 2017

Banzai Sushi Receives FDA Warning Letter

The FDA has sent a warning letter to Northwest Frozen LLC, doing business as Banzai Sushi, in Seattle, Washington. That seafood processing facility has serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations and Current Good Manufacturing Practice regulations for food. The facility must conduct or have conducted a hazard analysis for each kind of fish and fishery product produced. And an HACCP plan that lists the food safety hazards that are reasonably likely to occur. The firm's HACCP plan for "Frozen IQF Sushi Pieces" does not list the following food safety hazards: Clostridium botulinum growth and toxin formation; pathogenic bacteria growth and toxin formation; and undeclared allergens. The letter states that intact vacuum-packaged seafood … [Read more...]

Minnesota Lutefisk Manufacturer Gets FDA Warning Letter

Day Fish Company in Braham, Minnesota was inspected by the FDA from January 17 to January 23, 2017 and received a warning letter. The firm makes lutefisk from imported dried cod distributes pickled herring cutlets. According to the letter, the inspection revealed "serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (21 CFR), Part 123. hat means that fish or fishery products are adulterated. The refrigerated, ready to eat seafood products are adulterated "in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health." The firm must conduct a hazard analysis for each kind of fish and fishery product they produce along with a … [Read more...]

Whole Foods Closes Distribution Kitchens

A warning letter sent to the North Atlantic Whole Foods Market Kitchen in June 2016 listed problems at that facility that included the presence of non-pathogenic Listeria bacteria. Whole Foods has just announced it is closing some of its food distribution kitchens on the East coast. The warning letter detailed 20 "serious violations of the FDA's Current Good Manufacturing Practice regulations for manufacturing, packing, or holding human food." These violations included employees mixing ready to eat pesto directly under an area where condensate from ceiling joints was dripping onto the surface below; cutting chives and beets under a leaking condensate drainage pipe, and holding uncovered ready to eat egg salad in barrels placed below a condenser that was dripping. In addition, … [Read more...]

Camel Milk Company Warned Over Health Claims

The FDA sent a letter to Desert Farms of Santa Monica, California, telling them that the claims they are making about the products they produce classify them as drugs, and they cannot sell them through interstate commerce. The FDA has threatened to seize products and may seek an injunction against Walid Abdul-Wahab and his company if changes are not made. The company's Facebook page posts therapeutic claims that state the milk products are "intended for use in the cure, mitigation, treatment, or prevention of disease." The products in question for sale are Raw Camel Milk (Fresh); Raw Camel Milk (Frozen); Raw Camel Milk Kefir (Fresh); Raw Camel Milk Kefir (Frozen); Pasteurized Camel Milk (Fresh); Pasteurized Camel Milk (Frozen); and Raw Camel Milk 1st Colostrum (Frozen); Raw Camel … [Read more...]

Listeria Monocytogenes Found in Simply Fresh Fruit Facility

The FDA sent a warning letter on October 19, 2016 to Simply Fresh Fruit of Vernon, California, informing them that environmental swabs taken in their facility found Listeria monocytogenes bacteria. Federal inspectors also discovered violations of the Current Good Manufacturing Practices. These findings make the ready to eat fresh cut fruit products adulterated under the Federal Food, Drug, and Cosmetic Act. The FDA issued Form FDA-483 after the inspections. Three of one hundred environmental swabs in the facility's high care processing room were positive for Listeria bacteria. Two of those were in locations adjacent to food contact surfaces. They include the panel surface and power switch on the side of a wash bin, and a power knob for a conveyor belt. The other swab was found on a … [Read more...]

FDA Found Listeria Monocytogenes at Jeni’s Splendid Ice Cream

The FDA sent a warning letter to Jeni's Splendid Ice Cream's frozen flavor base Ohio manufacturing facility on August 9, 2016. The inspection that prompted the letter took place on January 25, 2016 through February 9, 2016. That letter states that "your frozen flavor base products are adulterated" because "FDA laboratory analysis of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. " A recall of Jeni's Splendid Ice Creams was initiated for possible Listeria monocytogenes contamination in April, 2015. All of the company's ice cream, frozen yogurt, sorbet, and ice cream sandwiches in all flavors and containers were recalled, and all scoop shops were closed. No illnesses were ever reported in connection to these … [Read more...]

FDA Warning Letter Sent to Lavella Brothers Warehouse

On June 23, 2016, the FDA sent a warning letter to Lavella Brothers food warehouse in Chester, Pennsylvania after an inspection on May 4 through May 26, 2016 found "significant violations of the FDA's Current Good Manufacturing Practice (cGMP) regulations. The violations "cause the food products stored at your facility to be adulterated, in that they were prepared, packed, or held under insanitary conditions whereby they may have been contamianted with filth or rendered injurious to health." The facility is also not registered with FDA. The violations included: not using water that is safe and of adequate sanitary quality in food and food-contact surfaces. The firm did not have running water in the restrooms, and the toilets and hand washing sinks were not functioning. There had … [Read more...]

FDA Warning Letter to Preferred Meal Systems of Illinois

The FDA sent a warning letter to Preferred Meal Systems in Illinois in February 2016, detailing violations of Current Good Manufacturing Practice in Manufacturing, Packing or Holding Human Food (CGMP) regulation. FDA inspectors collected environmeal samples that found Listeria monocytogenes in the facility. That facility makes ready-to-eat cold cut sandwiches and boxed lunches, for which there is zero tolerance for Listeria contamination. They also make non-RTE cooked frozen entrees and side dishes. The swabs that were positive for Listeria monocytogenes were taken in the Airline Production Room on the floor under the tomato sauce filler, in a square shaped hole, on the bottom of a shovel, in the floor drain, and on the floor near the roll up door to the dock area. In addition, they … [Read more...]

Harmless Harvest Thailand Sent FDA Warning Letter

The FDA sent a warning letter to Harmless Harvest Thailand last month, telling them that their 100% Raw Coconut Water products are considered hazardous, since they are processed in a manner that does not comply with the juice Hazard Analysis and Critical Control Point (HACCP) Systems regulation.  The juice products are considered adulterated within the meaning of the Federal Food, Drug, and Cosmetics Act. The firm provided documentation and information about the processing methods used to make this product. Those methods did not meet the FDA's regulation. The micro filtration process, risk assessment for that process, the HACCP plan and manual, and documentation about High Pressure Processing (HPP) were not adequate. The company must included control measures that will consistency … [Read more...]

FDA Warning Letter to Frito-Lay’s Tennessee Facility

The FDA has sent a warning letter to Frito-Lay's Tennessee facility, sating that inspections in May and June 2015 "revealed serious violations of FDA's Current Good Manufacturing Practice requirements." That means food products held at that facility are considered adulterated because they were "prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health." Frito-Lay has responded to Form FDA 483, and included a number of corrective actions. The adequacy of those actions will be assessed during the next inspection. The inspections in May and June revealed that the roof was leaky, often directly over exposed product through the facility. The equipment wash and sanitize bay, walls, and floor in the pretzel … [Read more...]

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