FDA Issued a warning Letter to Kerry from Beloit, WI, the Presumed Manufacturer of Kellogg’s ® Honey Smacks ® cereal

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
Kerry Inc 7/26/18

CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated

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