It may be worth reading the Consent Decree here. In fact, I suggest reading the Injunction Provisions starting on page 8, including the requirements for development and implementation of a Salmonella Monitoring Plan (F.1.) on page 10. While there have been no reported illnesses, FDA found Salmonella is the facility and the facility did not appear to take sufficient action. This can be seen as what is to come for FDA facilities with FSMA and the new tool of whole genome sequencing.
FDA Press Release
https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm531188.htm
Food regulators seize adulterated milk products for food safety violations
UPDATE: On March 14, 2017, Judge Elizabeth K. Dillon of the United States District Court for the Western District of Virginia entered a consent decree of condemnation and permanent injunction against Valley Milk Products LLC (Strasburg, VA), and three individuals, General Manager Michael W. Curtis, Plant Manager Robert D. Schroeder, and Quality Control Compliance Officer Jennifer J. Funkhouser. The seized milk powder products have been condemned and forfeited to the United States. The company may attempt to bring the condemned products into compliance but only under the supervision of the FDA, and it may not resume manufacturing powdered milk products without first implementing corrective action. The action does not affect liquid milk products made by the company. More information can be found on www.pacer.gov (case number 5:16cv76). No illnesses have been reported to date associated with these products. Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator.
November 30, 2016
The U.S. Food and Drug Administration announced today that the U.S. Marshals Service seized more than 4 million pounds of product produced by Valley Milk Products LLC (Valley Milk) of Strasburg, Virginia. The company is owned by the Maryland and Virginia Milk Producers Cooperative Association Inc. in Reston, Virginia. The seized products include dry nonfat milk powder and buttermilk powder packaged in 40- and 50-pound bags for further manufacturing and are worth nearly $4 million.
The U.S. Department of Justice filed the complaint, on behalf of the FDA, in the U.S. District Court for the Virginia Western District, alleging that the seized products are adulterated under the Federal Food, Drug, and Cosmetic Act.
During an FDA inspection of Valley Milk from July – September 2016, FDA investigators observed poor sanitary practices and reviewed the company’s records, which showed positive results for Salmonella in the plant’s internal environmental and finished product samples. FDA investigators observed residues on internal parts of the processing equipment after it had been cleaned by the company and water dripping from the ceiling onto food manufacturing equipment. In addition, environmental swabs collected during the inspection confirmed the presence of Salmonella meleagridis on surfaces food came into contact with after being pasteurized. Throughout the investigation, the FDA worked closely with the Virginia Department of Health and Virginia Department of Agriculture and Consumer Services.
"The FDA urged Valley Milk to conduct a voluntary recall of the implicated products," said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. "The firm refused to recall and, as a result, we have had to intervene and seize this adulterated food to prevent it from reaching consumers who could be exposed to Salmonella from these products."
The FDA used a bacterial typing tool called whole genome sequencing (WGS) to link the samples collected in the facility over time. WGS technology can show the relationship among isolates of bacterial pathogens found in the environment, a food source or a person who became ill from consuming contaminated food. The sampling results indicate that the Salmonella strains from 2016 are nearly identical to Salmonella strains found at the company in 2010, 2011 and 2013. These findings of Salmonella meleagridis at the company dating back several years demonstrate the existence of a persistent strain of Salmonella at this facility.
Salmonella is a pathogenic bacterium that can contaminate foods and which may result in gastroenteritis or other serious clinical conditions, including septicemia, arterial infections, endocarditis and septic arthritis. Most people recover from salmonellosis in four to seven days without treatment but about one person in every thousand with salmonellosis dies.
Valley Milk is currently not producing dry powdered milk products. No illnesses linked to Valley Milk products have been reported to date. Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm531188.htm
Food regulators seize adulterated milk products for food safety violations
UPDATE: On March 14, 2017, Judge Elizabeth K. Dillon of the United States District Court for the Western District of Virginia entered a consent decree of condemnation and permanent injunction against Valley Milk Products LLC (Strasburg, VA), and three individuals, General Manager Michael W. Curtis, Plant Manager Robert D. Schroeder, and Quality Control Compliance Officer Jennifer J. Funkhouser. The seized milk powder products have been condemned and forfeited to the United States. The company may attempt to bring the condemned products into compliance but only under the supervision of the FDA, and it may not resume manufacturing powdered milk products without first implementing corrective action. The action does not affect liquid milk products made by the company. More information can be found on www.pacer.gov (case number 5:16cv76). No illnesses have been reported to date associated with these products. Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator.
November 30, 2016
The U.S. Food and Drug Administration announced today that the U.S. Marshals Service seized more than 4 million pounds of product produced by Valley Milk Products LLC (Valley Milk) of Strasburg, Virginia. The company is owned by the Maryland and Virginia Milk Producers Cooperative Association Inc. in Reston, Virginia. The seized products include dry nonfat milk powder and buttermilk powder packaged in 40- and 50-pound bags for further manufacturing and are worth nearly $4 million.
The U.S. Department of Justice filed the complaint, on behalf of the FDA, in the U.S. District Court for the Virginia Western District, alleging that the seized products are adulterated under the Federal Food, Drug, and Cosmetic Act.
During an FDA inspection of Valley Milk from July – September 2016, FDA investigators observed poor sanitary practices and reviewed the company’s records, which showed positive results for Salmonella in the plant’s internal environmental and finished product samples. FDA investigators observed residues on internal parts of the processing equipment after it had been cleaned by the company and water dripping from the ceiling onto food manufacturing equipment. In addition, environmental swabs collected during the inspection confirmed the presence of Salmonella meleagridis on surfaces food came into contact with after being pasteurized. Throughout the investigation, the FDA worked closely with the Virginia Department of Health and Virginia Department of Agriculture and Consumer Services.
"The FDA urged Valley Milk to conduct a voluntary recall of the implicated products," said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. "The firm refused to recall and, as a result, we have had to intervene and seize this adulterated food to prevent it from reaching consumers who could be exposed to Salmonella from these products."
The FDA used a bacterial typing tool called whole genome sequencing (WGS) to link the samples collected in the facility over time. WGS technology can show the relationship among isolates of bacterial pathogens found in the environment, a food source or a person who became ill from consuming contaminated food. The sampling results indicate that the Salmonella strains from 2016 are nearly identical to Salmonella strains found at the company in 2010, 2011 and 2013. These findings of Salmonella meleagridis at the company dating back several years demonstrate the existence of a persistent strain of Salmonella at this facility.
Salmonella is a pathogenic bacterium that can contaminate foods and which may result in gastroenteritis or other serious clinical conditions, including septicemia, arterial infections, endocarditis and septic arthritis. Most people recover from salmonellosis in four to seven days without treatment but about one person in every thousand with salmonellosis dies.
Valley Milk is currently not producing dry powdered milk products. No illnesses linked to Valley Milk products have been reported to date. Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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