December 7, 2021

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...]

FDA Warning Letters April 26, 2014: Hahn’s, Diondillo’s, Pancrazio

The FDA has sent warning letters to three corporations this week for problems with their product safety. Hahn's Old Fashioned Cake Company was warned for food packed or held under insanitary conditions, as was Biondiollo's Bakery. Pancrazio S.P.A. was cited for violating low acid canned food regulations. Hahn's Old Fashioned Cake Company was cited for "serious violations of FDA's Current Good Manufacturing Practice requirements." The corporation did not have adequate cleaning processes for equipment and prep tables. THe product packaging line was "observed to be encrusted with flour, sugar, and filth." In addition, pests were not excluded from the processing areas. Six birds were observed flying around the production area; a bird was defecating while on a rafter above uncovered finished … [Read more...]

FDA Says Illegal Products Claim Treatment for Diabetes

The FDA is warning consumers that some dietary supplements are illegally claiming that they can cure or treat diabetes. More alarming, some of these products contain harmful and unsafe ingredients. The agency issued warning letters to 15 companies that their products violate the law. These products were sold online and in retail stores. The products include Sugar Balancer by Health King Enterprises, Eradicator by Naturecast Products, Diabetes Daily Care by Nature's Health Supply, Glucocil by Neuliven Health, and Zostrix Creams by Health Care Products, among others. The FDA says that "consumers with diabetes risk serious health complications by choosing illegally sold diabetes products, which m ay also be dangerous. Bogus diabetes products are flooding the marketplace, especially the … [Read more...]

FDA Warning Letter to Kenny’s Farmhouse Cheese

In October 2012, Kenny's Farmhouse Cheese was recalled for possible Listeria monocytogenes contamination. So while browsing through today's released FDA warning letters sent to facilities and plants in the last two months, we were interested to see a warning letter to that company dated 12/11/2012. The FDA inspected the cheese manufacturing plant in August 2012 and found the presence of Listeria monocytogenes in 29 out of 85 environmental swabs. Twelve of the positive samples were taken from food contact  surfaces and seventeen from non-food contact areas. There were also significant violations of the Current Good Manufacturing Practice (CGMP) regulation for manufacturing, packing, or holding human food. That means that the food was "prepared, packed, or held under insanitary … [Read more...]

Two Egg Production Facilities Warned by FDA

Two egg production facilities have received warning letters from the FDA about violations of the shell egg regulation called the Egg Safety Rule. That regulation is Title 21, Code of Federal Regulations, Part 118 (21 CFR 118). The two facilities are SKS Enterprises, Inc. located in California, and Midwest Poultry Services, located in Indiana. Both of these facilities are members of the American Egg Board. SKS Enterprises was warned about five of their farms, all located in California. The letter states that the eggs were "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." The violations include failure to conduct environmental testing for Salmonella Enteritidis (SE), … [Read more...]

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