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...]
Whole Leaf Stevia Isn’t Considered GRAS
Many foods contain a chemical from Stevia, which is a herb that is very sweet and doesn't add calories to food. It is considered a sugar substitute, the only one made from a plant (not in a factory) and it is 200 times sweeter than sugar. But in a warning letter to the Ten Ren Tea Company of San Francisco, the FDA told them that whole leaf Stevia is not on the generally regarded as safe (GRAS) list. Whole Stevia leaves and "crude Stevia extracts" are not approved as food additives. The FDA has received petitions for the use of whole-leaf Stevia and its crude extracts in food, but data to support its safe use have been lacking, according to the government. Literature reports raise safety concerns about the use of these forms of the plant. There are concerns about effects of whole … [Read more...]
FDA Warning Letters for September 2014
The FDA has sent many warning letters to corporations during the month of September 2014. These letters inform the corporation owners of problems with food safety and HACCP violations. Well Luck Company in New Jersey received a letter on September 17, 2014 warning about rodent problems at their facility. Live mice were spotted in the facility during an inspection. Dead mice were found on glue traps in the picking area and next to the cooler entrance door. A dead rat was found in a rodent trap in the warehouse storage area. In addition, roach-like insects "too numerous to count" were in the fortune cookie processing room. Equipment was not properly stored, litter and waste was not removed, and food products were spilled onto the warehouse floor. Losurdo Foods of New Jersey was warned … [Read more...]
FDA Warning Letters for September 2014
The FDA has sent a warning letter to M & B Sea Products of New Bedford, Massachusetts, alleging that the facility has "serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation." The company's refrigerated, reduced oxygen packaged raw, scallops are adulterated. The facility does not have an HACCP plan to list critical limits to be met. Because the scallops were not refrigerated at a temperature below 38°F, Clostridium botulinum toxin can form. FDA inspectors found fresh dry scallops packed in metal cans stored in the walk-in cooler, which meant they could not be visually examined. The firm did not maintain monitoring records for two days in July 2014. In addition, the company did not have anyone trained in seafood HACCP to perform necessary … [Read more...]
FDA to Airplane Food Maker: Don’t Let Ceiling Drip Into Food
Whatever it is that is dripping from the ceiling might be getting into the food at Gourmail Inc., dba Jyoti Natural Food, according to the U.S. Food and Drug Administration (FDA) which sent a warning letter to the company last week. Conditions at the company's plant, in Sharon Hill, Pa., that the airline food prepared there was "prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health." During an inspection, FDA investigators found water dripping into a kettle of food. Although company officials say that batch of food was destroyed, they did not take adequate measures to correct the problem by placing a tarp on the roof. They were also unable to provide a timeframe for when the repair could be made. Stained … [Read more...]
