The FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation. Based on FDA’s inspectional findings and the analytical results for the environmental samples collected during the inspection, FDA determined that the cereal manufactured in the facility is adulterated because it was prepared, packed or held under insanitary conditions. Some of the reasons for the letter include the fact that the hazard analysis for the cereal did not identify contamination of RTE cereal with the environmental pathogen of Salmonella as a food safety hazard requiring a preventive control. Salmonella was repeatedly found in the environment (81 positive samples and 32 positive vector samples) without corrective action procedures that must be taken if preventive controls are not properly implemented. Additionally, the facility did not implement sanitation corrective action procedures and did not verify that sanitation preventive controls are consistently implemented and are effectively and significantly minimizing or preventing a hazard with environmental monitoring as required. @ https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm615073.htm
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CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
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July 30, 2018 – The USDA/FSIS issued an alert due to concerns about contamination of beef, pork and poultry salad and wrap products were distributed by Caito Foods LLC, an Indianapolis, with Cyclospora. The products were produced on July 15 to 18, 2018. Boar’s Head, Trader Joe’s, GFS, and Walgreens are some of the names associated with the recall. The problem was discovered when Caito Foods received notification from their lettuce supplier, Fresh Express, that the chopped romaine that was used to manufacture some of their salads and wraps was recalled. FSIS is concerned that some product may be in consumers’ refrigerators and that consumers may be at risk due to the length of the Cyclospora incubation period. @ https://www.fsis.usda.gov/wps/portal/fsis/newsroom/news-releases-statements-and-transcripts/news-release-archives-by-year/archive/2018/pha-07302018-1
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert out of an abundance of caution due to concerns about contamination with Cyclospora.
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A multi-country (United Kingdom (129 cases), Finland (15), Denmark, Germany and Ireland (one case each)) outbreak of Salmonella Agona (S. Agona) is under investigation in the European Union (EU), with cases retrospectively identified back to 2014. Overall, 147 outbreak cases have been reported. The outbreak was first detected in the United Kingdom using WGS. Seventeen S. Agona food isolates from 2018, detected in the, were found to be closely genetically related to the human strains. The food isolates were from cucumbers sampled during processing before and after washing (11 isolates) and ready to eat (RTE) food products containing cucumbers (six isolates). The microbiological evidence suggests RTE products containing cucumbers as a possible vehicle of infection but so far it has not been possible to identify the specific point in the production chain where the contamination occurred. Although the cucumbers used in all final contaminated products originated from Spain for a limited period (from November 2017 to April 2018), no connection between supply chains was identified @ https://www.efsa.europa.eu/sites/default/files/scientific_output/EN-1465.pdf
https://www.efsa.europa.eu/sites/default/files/scientific_output/EN-1465.pdf
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Lipari Foods, recalled Premo Brand and Fresh Grab turkey and Swiss submarine sandwiches produced and packaged by JLM (a sister company of Lipari)due to potential contamination with Listeria monocytogenes. The products were produced on July 17, 2018 and distributed to food service and retail stores throughout Florida, Illinois, Indiana, Kentucky, Michigan, Minnesota, Ohio, Pennsylvania, Tennessee, Wisconsin and West Virginia. The products were distributed under the names of Premo Brand & Fresh Grab. This was brought to The FDA attention by JLM after recent routine environmental monitoring and product testing initiated found a positive test results for Listeria monocytogenes. No illnesses have been reported to date in connection with this problem. @ https://www.fda.gov/Safety/Recalls/ucm615055.htm
Lipari Foods, LLC has issued a voluntary recall of Premo Brand and Fresh Grab turkey and Swiss submarine sandwiches produced and packaged by sister company JLM due to potential contamination of Listeria monocytogenes. Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.