April 1, 2020

Fuji Foods Sushi Facility Receives FDA Warning Letter For Listeria

Fuji Foods sushi facility has received an FDA warning letter for Listeria contamination in their facility. That company, located at 121 Liberty Street in Brockton, Massachusetts, recalled ready-to-eat sushi, salads, and spring rolls under the brand names Trader Joes and Okami on November 27, 2019 for Listeria monocytogenes contamination. No illnesses were reported in connection with that recall. The warning letter states that environmental samples from different areas in the facility, including food-contact surfaces and areas near food, tested positive for Listeria monocytogenes. The FDA also found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation during the inspection. Because of the results of the inspection, the company's … [Read more...]

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 Releases 2020 Leafy Greens Action Plan After Romaine E. coli. Outbreaks

The FDA has released its 2020 Leafy Greens STEC Action Plan after the E. coli O157:H7 outbreaks linked to romaine lettuce in the past few years sickened hundreds. In fact, in 2019 alone, there were three E. coli O157:H7 romaine lettuce outbreaks that sickened more than 170 people and hospitalized more than 85 patients. Between 2009 and 2018, the FDA and the Centers for Disease Control and Prevention (CDC) identified 40 foodborne outbreaks of Shiga toxin-producing E. coli (STEC) infections in the U.S. with a confirmed or suspected link to leafy greens. This illness can cause serious and life-threatening complications, including hemolytic uremic syndrome (HUS), a type of kidney failure. Part of the problem is the nature of leafy greens and especially romaine lettuce. Most are grown … [Read more...]

FDA Lists Jimmy John’s Sprout Outbreaks in Warning Letter

The FDA has finally sent a warning letter about Jimmy John's sprout outbreaks in the wake of the latest one: an E. coli O103 outbreak that has sickened at least 22 people in Iowa that is lined to raw clover sprouts produced by Sprouts Unlimited of Marion, Iowa. There are five food poisoning outbreaks linked to that restaurant chain that go back to 2012, and more earlier than that. These are the outbreaks listed in the FDA warning letter: The current E. coli O103 outbreak is linked to 15 Jimmy John's restaurants in Iowa. Clover sprouts from Sprouts Unlimited are the culprit. At least 22 people are sick. Illness onset dates range from November 21, 2019 to December 14m 2019. In 2018, at least 10 people were sickened with Salmonella Montevideo infections after eating raw sprouts … [Read more...]

FDA Addresses Issue of China Coronavirus and Imported Products

On our Facebook page recently, one person asked if anyone should be concerned about the safety of products arriving from China as the coronavirus outbreak continues. The virus has been named COVID-19, as it is a virus causing coronavirus disease that was first identified in 2019. Is there a danger regarding coronavirus and imported products? The FDA is working to surveil the medical product supply chain and is using enforcement tools to oversee the safety and quality of FDA-regulated products. The FDA isn't able to conduct inspections in China now, as the U.S. State Department's Travel Advisory is not to travel to China because of the outbreak. Here's the takeaway line: "Fortunately, currently, we are not seeing the impacts of this outbreak resulting in an increased public health … [Read more...]

Supermarkets Are Failing To Post Food Recalls, Says U.S. PIRG

A new report by the U.S. PIRG (public interest research groups) has found that most supermarkets are failing to post food recalls and don't make it easy for consumers to find out about recalled products. The report is titled, "Food Recall Failure: Will your supermarket warn you about hazardous food?" It gave a failing grade to 84% of the nation's 26 largest supermarket chains. Some of the chains that received a failing grade include Aldi, Publix, Whole Foods, Safeway, Albertsons, HEB, Meijer, Stop & Shop, Trader Joe's, Food Lion, and Walmart. Those supermarkets are failing to post food recalls. U.S. PIRG Education Fund Consumer Watchdog Adam Garber said in a statement, "Supermarkets should be our best recall notification system, but instead, we found that shoppers must go on … [Read more...]

FDA Alerts Consumers to Dangers of Cesium Salts in Supplements

The FDA Is issuing a public health alert about dietary supplements that contain cesium salts, primarily cesium chloride. This ingredient has significant safety risks, including heart toxicity and potential death. The FDA is also alerting health care professionals about the risks of cesium salts, which are sometimes promoted as alternative treatments for cancer. Cesium salts have never been proven to be safe and effective to treat cancer or for any other use. While only a few dietary supplements on the market contain this ingredient, consumers should not purchase those products. According to the alert, there have been"multiple clinical case reports and non-clinical studies show significant safety concerns related to the use of such products, including potentially fatal cardiac … [Read more...]

Leafy Greens Industry Frustrated By Recurring E. coli Outbreaks

Will there be another E. coli outbreak linked to leafy greens this year? Since 2017, there has been at least one multistate E. coli O157:H7 outbreak linked to romaine lettuce every year. Outbreaks linked to packaged salads and other leafy greens go back to 2010. And every year, the outbreak is unsolved, with the FDA and CDC unable to pinpoint where the contaminated greens originated. The leafy greens industry is frustrated. The California Leafy Greens Marketing Agreement group (LGMA) adopted new rules for its members last year, asking them to increase the buffer zone between between farm fields and animal feedlots, to clean equipment daily, to improve traceability, and to review the impact of severe weather on crops. Growers should now categorize the source of water used on their … [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...]

FDA Issues Health Alert Over Nopalina Flax Seed For Salmonella

The FDA has issued a public health alert about Nopalina Flax Seed Powder and Nopalina Flax Seed Capsules for possible Salmonella contamination. These products were manufactured by Salud Natural Entrepreneur, Inc. The recalled products include: Nopalina Flax Seed Fiber (powder, 1 lb. bags) Lot # 62.19/9#52.1 Best if used by 10/7/21 Lot # 62.19/2#52.1 Best if used by 10/7/21 Nopalina Flax Seed Fiber (powder, 1 lb. bags) Lot # 64.19/3#52.1 Best if used by 10/21/21 Nopalina Flax Seed Fiber (powder, 2 lb. bags) Lot # 64.19/2#52.1 Best if used by 10/21/21 Lot # 64.19/2*2Lb#52.1  Best if used by 10/21/21 Nopalina Flax Seed Fiber (powder, 1 lb. bags) Lot # 65.19/1#52.1 Best if used by 10/24/21 Lot # 65.19/2#52.1 Best if used by 10/24/21 Nopalina Flax … [Read more...]

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