The Kellogg’s Honey Smacks salmonella outbreak that sickened 135 people in 36 states traced back to a plant in which salmonella had been found multiple times from September 2016 through May 2018, an FDA warning letter said.
But the Gridley, Illinois, plant run by Wisconsin-based Kerry, Inc. didn’t do enough to protect the cereal from getting salmonella and carrying it to the masses.
Friday’s update on the outbreak from the FDA was the first outbreak update that mentioned Kerry, Inc..
In a Friday email to the Miami Herald, FDA spokesman Peter Cassell said, “The FDA, CDC, along with state and local officials investigated a multi-state outbreak of Salmonella Mbandaka infections linked to Kellogg’s Honey Smacks sweetened puffed wheat cereal. The FDA worked with Kellogg’s to voluntarily recall Honey Smacks from the market and conducted an inspection at the manufacturing facility owned by Kerry, Inc., resulting in a warning letter identifying specific problems at the facility.
“The FDA is working with Kellogg’s to ensure Honey Smacks are safe when they are again available to consumers and is continuing to warn consumers against eating any Honey Smacks with a marked “best if used by” date before June 14, 2019.
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The warning letter was dated July 26, 2018 and was posted on the FDA site with the subject line “CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated.”
CGMP stands for Current Good Manufacturing Practice and the letter said, “During our inspection of your facility, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.”
The FDA inspected the Kerry facility from June 14, the day of the initial recall, through June 29. One of the places the FDA swabbed for a sample was a rollup door between the cereal coating room and the processing room for rice crisps that were going in pet food.
“The failure of your sanitation controls to significantly minimize or prevent the environmental hazard of Salmonella is reflected in three FDA environmental samples that were positive for the same strain of salmonella,” the letter reads. “The failure is further evidenced by your 81 positive salmonella environmental samples and 32 positive salmonella vector samples (samples taken in response to finding a positive on routine testing) between Sept. 29, 2016 and May 16, 2018.”
Among those positive samples were four samples from the cereal coating room and “repeated findings of other salmonella species in some production lines and rooms used for the manufacture of cereal.”
Yet, nothing was done to the Honey Smacks to “significantly minimize the pathogen,” the letter said. Meanwhile, as prevention of salmonella had failed, the FDA said the Kerry facility didn’t take corrective steps once it found the salmonella.
“Your facility completed an “Environmental Investigation Report” for each positive pathogen sample you found,” the letter acknowledges. “However, there is no documentation that you formed a response team to determine the root cause and corrective actions necessary to prevent the routine recurrence of salmonella throughout your facility during the time period of Sept. 29, 2016 to May 16, 2018.”
A Friday evening email from Kerry said, in part:
“As a result of the FDA findings, we developed a comprehensive corrective action plan for the facility. We have now thoroughly reviewed our preventive controls and compliance measures at this site and have taken corrective measures, including:
▪ Performed a full review of the facility and implemented changes to our hygienic zoning and traffic control programs.
▪ Updated our environmental monitoring program.
▪ Reengineered certain equipment to improve its sanitary design.
▪ Enhanced training and auditing to ensure programs are implemented as written.”