Lyons Magnus states an overview of the FDA warning:
- from: The FDA issued a warning letter to Leon Magnus.
- because: The US Food and Drug Administration says its inspection of a Leon Magnus processing facility shows it was violating food safety regulations, after a major recall of its products in 2022.
- where: The processing plant is located in Beloit, Wisconsin.
The US Food and Drug Administration (FDA) has issued a warning to Lyons Magnus after a Major withdrawal 2022 Its Glucerna, Stumptown, Intelligentsia, Aloha, Kate Farms and Premier Protein brand products led to the discovery that one of the company’s processing facilities was violating food safety regulations.
In July 2022, Lyons Magnus LLC recalled 53 food and beverage products due to potential microbial contamination, including by Cronobacter sakazakii. in August Extended withdrawal to over 100 additional products.
In a warning letter dated January 30, the FDA indicated an inspection of the Leon Magnus sterile processing facility in Beloit, Wisconsin, between August 3 and September 14, 2022.
The FDA stated that the inspection was initiated in response to the company’s recall in July 2022 and the lack of commercial sterilization of its finished products.
The FDA believes that positive lab results were not immediately reported
An FDA examination revealed that the company did not comply with regulations for emergency permit control and regulations for low-acid foods that are heat-treated and packaged in airtight containers.
According to the FDA, some serious violations involve failure to immediately report the contamination to the FDA. According to the Food and Drug Administration, a batch of food that may be harmful to health due to its full or partial contamination with microorganisms must be reported to the distribution circuit.
Although the company reported a voluntary recall to the Food and Drug Administration on July 26, 2022, an FDA review of microanalysis records revealed the presence of Gram-positive, Gram-negative Bacillus cocci and cocci in approximately 37 items of finished products that were put on sale that were sold and shipped, but not It is reported to the Food and Drug Administration.
“The FDA has reminded the company that its aseptically packaged products containing viable microorganisms do not meet the definition of commercial sterility and are therefore adulterated,” the FDA said in the warning.
“The shipment of adulterated products to interstate commerce is prohibited. The company should urgently alert the FDA of quantities shipped with known bacterial contamination, not just lots of confirmed types such as those identified in July 2022.”
In addition, the company shipped the products without fully investigating the cause of the bacterial contamination, according to the FDA.
The FDA also said that commercial sterility was not immediately guaranteed in a facility. He said that although Lions Magnus was aware of the microbiological contamination as of April 2022, the company did not cease processing until July 15, 2022, and launched an internal investigation on July 16, 2022.
Last year, Lions Magnus was the subject of a class action lawsuit alleging this This is not guaranteed quality of its products.
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