June 3, 2020

Gourmet Catering to Go Warning Letter Details Roaches, Rodents, and Mold

The FDA has sent the company Gourmet Catering to Go a warning letter detailing the violations of Good Manufacturing Practice after an inspection in September and October 2019. That facility is located at 801 Hanger Lane in Nashville, Tennessee. Inspectors found mold, rodent excreta pellets, and dead cockroaches at the facility. The company makes ready to eat meals and food for the airline industry. Based on the FDA's findings, the ready to eat products made in that facility are adulterated "because they 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 FDA issued a Form-483 listing all of the deviations that were uncovered during the inspection. Gourmet … [Read more...]

FDA Warning Letter Sent to TX Country Fresh Over Listeria Findings

The FDA has sent a warning letter to Country Fresh of Spring, Texas, about Listeria monocytogenes that was found in their facility that produces fresh, ready-to-eat produce. Inspections of the facility "found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation (CGMP and PC Rule), Title 21, Code of Federal Regulations (CFR), Part 117 (21 CFR Part 117)," according to the letter. Inspectors took swabs of the environment, including areas near food processing operations, and found Listeria monocytogenes. That means that the ready-to-eat products are adulterated within the meaning of the Federal Food, Drug, and Cosmetic Act. No illnesses have been reported in connection with any Country Fresh … [Read more...]

Life Rising Dietary Supplements Seized by U.S. Marshals

U.S. Marshals seized more than 300,000 containers of dietary supplements from Life Rising Corporation in June 2019 at the request of the FDA. The seized goods included tablets, capsules, and teas. The brand names for some of the 500 products are Life Rising, Holicare, or HopeStream. The U.S. District Court for the Northern District of Illinois found that there was probable cause that "the company prepared, packed, and/or held dietary supplements under conditions that do not conform to the dietary supplement current good manufacturing practice (CGMP) requirements," according to the FDA news release. The FDA issued an Administrative Detention Order in May 2019 to prevent these products from reaching consumers until they could be seized based on these violations. Melinda K. … [Read more...]

FDA Warns Velvet Ice Cream Company About Listeria Monocytogenes

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 not heat the food before eating, which would kill the pathogen. Once Listeria is introduced into a facility, it can become persistent and be very difficult to eradicate. In fact, there have been several issues with Listeria contamination in ice cream plants for the past few years. In April 2019, the FDA stated they were taking steps to improve ice cream production after finding the pathogen in 19 of the 89 ice cream … [Read more...]

FDA Warns Homeopathic Product Manufacturers

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 a system in place that makes sure there is proper design, monitoring, and control of the manufacturing process. FDA Acting Commissioner Dr. Ned Sharpless said in a statement, "It’s our public health obligation to protect consumers from unsafe products. Our manufacturing requirements are designed to ensure the quality and safety of drugs distributed to American consumers, and the FDA expects companies to … [Read more...]

FDA Warns Homeopathic Drug Producers For Violations of CGMP

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 marketed for serious diseases and the product has not been shown to offer clinical benefits. Products labeled as homeopathic have not been approved by the FDA for any use and may even not meet standards for quality and safety, according to the FDA. These products may be made from plants, healthy or diseased animal or human sources, minerals, and chemicals. They are marketed as natural, safe, and … [Read more...]

FDA Warns Nutra Pharma Group For Illegally Marketed Unapproved Products

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 Nyloxin Oral Spray, Nyloxin Topical Gel, Nyloxin Topical Roll-On, Nyloxin Topical Roll-On ES, Nyloxin Professional Size Pump Topical Gel and Regular Strength Sample Pack. These names are similar to other FDA-approved drugs and may confuse consumers. The claims on these products include "treats conditions that cause chronic pain," and "Cobra venom saw its primary use in the treatment of cancer and … [Read more...]

FDA Sends Warning Letter to Maker of Necco Wafers and Sweethearts

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 Food regulation." The violations included "significant evidence of rodent activity and insanitary conditions" throughout the facility. That means the candy products are adulterated. FDA inspectors found evidence of rodent activity in the food storage areas of the facility. Rodent excreta pellets that were too numerous to count and evidence of widespread rodent activity were found in "multiple areas" throughout the … [Read more...]

FDA Warns Companies That Make Coco Loko and Legal Lean as Unapproved New Drugs

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 the promotional materials for the products demonstrate they are intended to be used as alternatives to street drugs. These products, as labeled and marketed, "may pose safety concerns," according to the press release. The FDA is concerned that these products encourage drug abuse in individuals, including minors. These street drug alternatives are used for recreational purposes to affect psychological states. FDA Commissioner Scott Gottlieb said … [Read more...]

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...]

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