A fast-moving, but somewhat secretive federal prosecution has extracted guilty pleas for three misdemeanors from the quality assurance director for a food manufacturer working for the Kellogg Company.
Ravi Kumar Chermala, 47, pleaded guilty on Oct. 21 to three misdemeanor counts of Introducing adulterated food into Interstate Commerce. It was part of a plea deal that is among a half dozen documents in the case that are sealed, and therefore not available for public viewing. The federal Magistrate for the Central District of Illinois, Jonathan P. Hawley, has scheduled sentencing for Jan. 30. 2023.
The charges stem from the multistate outbreak of Salmonella Mbandaka infections from Kellogg’s Honey Smacks cereal, which sickened 135 people in 35 states in 2018. The infections required hospitalizations for 34 patients. The Kellogg Company recalled Honey Smacks cereal on June 14, 2018.
According to federal prosecutors, Chermala was quality assurance director for various Kerry manufacturing plants, including a facility in Gridley, IL, that manufactured Kellogg’s Honey Smacks breakfast cereal for Kerry’s customer, the Kellogg Company.
At the time of the recall, the Kellogg Company said it “had launched an investigation with the third-party manufacturer who produces Honey Smacks,” naming Kerry’s possible role.
In pleading guilty to the three misdemeanors, Chermala admitted that between June 2016 and June 2018, he directed subordinates to not report certain information to Kellogg’s about conditions at the Gridley facility.
In addition, Chermala admitted that he directed subordinates at the Gridley facility to alter the plant’s program for monitoring the presence of pathogens in the plant, limiting the facility’s ability to accurately detect unsanitary conditions.
“Food safety professionals cannot conceal potentially dangerous problems from customers or government regulators,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The department will continue to work with its law enforcement partners to hold accountable those who engage in such conduct.”
Special Agent in Charge Lynda M. Burdelik of the FDA Office of Criminal Investigations in the Chicago field office said this prosecution “reinforces that if an individual violates food safety rules or conceals relevant information, we will seek to hold them accountable. The health of American consumers and the safety of our food are too important to be thwarted by the criminal acts of any individual or company.”
Salmonellosis can cause symptoms such as diarrhea, fever, and abdominal cramps that last several days in healthy adults. Absent prompt treatment, salmonellosis can cause severe dehydration and even death in infants, young children, the elderly, transplant recipients, pregnant women, and individuals with weakened immune systems.
Further information about the case will be posted to the department’s Information for Victims in Large Cases website at https://www.justice.gov/largecases.
Trial Attorney Cody Matthew Herche and Senior Trial Attorney James T. Nelson of the Department of Justice, Civil Division’s Consumer Protection Branch are prosecuting the case.
The misdemeanor counts in the case were filed with the court on Aug. 23, 2022. Defense attorneys Jesse Mentz and Michael Kim Krouse are both from the multinational law firm of Arnold & Porter Kaye Scholer.
At the time of the Honey Smack recall, Kerry was subject to an FDA inspection that went to upper management. The resulting warning letter said in part:
“The United States Food & Drug Administration (FDA) inspected your Kerry Inc. facility, located at 320 West Gridley Road, Gridley, IL 61744-8723, from June 14 to 29, 2018. The inspection was initiated as (redacted) in three environmental swabs taken from your (redacted) cereal (“cereal”) production rooms during FDA’s inspection. Further, the FDA’s Whole Genome Sequencing (WGS) analysis of the three isolates of (redacted).
“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 (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117).
“Based on FDA’s inspectional findings and the analytical results for the environmental samples collected during the inspection, we determined that the cereal manufactured in your facility is adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 342(a)(4) in that it was prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act (21 U.S.C. § 331(uu)).”
FDA’s inspection resulted in the issuance of an FDA Form-483 (FDA-483), Inspectional Observations, listing deviations found during the inspection. It went to Kerry’s CEO in Beloit, WI.
Court documents are silent as to whether or not others are responsible for the outbreak. With six of 11 items docketed in the case begin sealed, it is difficult to reach a complete picture.
(To sign up for a free subscription to Food Safety News,click here)
