The FDA has sent a warning letter to the Velvet Ice Cream Company of Utica, Ohio, that Listeria monocytogenes has been found in their facility during inspection. The company makes ready-to-eat ice cream. There is zero tolerance for Listeria monocytogenes bacteria in ready-to-eat products, including deli meats and cheeses and ice cream because the consumer does … Read more
The Food and Drug Administration (FDA) is warning five homeopathic product manufacturers for significant violations of current good manufacturing practice regulations (CGMP). Warning letters were sent to those companies. Four of the letters target companies who jointly produced a product labeled as homeopathic that was not sterile. The fifth outlines a company’s failure to have … Read more
The FDA has sent warning letters to four homeopathic drug producers for “significant violations of current food manufacturing practice (CGMP) regulations.” These products are labeled as homeopathic and marketed without FDA approval. The homeopathic industry has grown tremendously in the past several years. The government acknowledges the need to address situations where these products are … Read more
The FDA posted a warning letter to Nutra Pharma Corporation for illegally marketing unapproved products that were labeled as homeopathic and made medical claims. More specifically, the claims were about ability to treat addiction and chronic pain, including pain that is associated with cancer, diabetes, fibromyalgia, and other serious medical conditions. The targeted products include … Read more
The FDA has sent a warning letter to the maker of Necco Wafers and Sweethearts about the conditions in their facility. The letter was sent to the New England Confectionary Company in Massachusetts. The inspection conducted late last year found “serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human … Read more
The FDA is warning makers and manufacturers of two products, Legal Lean Syrup, a drink, and Coco Loko, a “snortable” chocolate powder, for selling unapproved new drugs and misbranded drugs. These products are promoted as alternatives to street drugs. The government has sent a warning letter to one company about this problem. Claims made in … Read more
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 … Read more
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 … Read more
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 … Read more
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 … Read more