November 23, 2024

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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