Kerry’s former quality assurance director pleads guilty to Honey Smack outbreak

This story by Dan Flynn first appeared in Food Safety News on October 24, 2022, and is reposted here with permission.


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 being sealed, it is difficult to reach a complete picture.

Op-Ed. FDA acknowledges Kellogg – Kerry tie in Honey Smacks cereal outbreak

Now that the outbreak is over and the question is purely academic, FDA has acknowledged Kerry Inc. to be the manufacturer behind the Salmonella Mbandaka outbreak linked to contaminated Kellogg’s Honey Smacks breakfast cereal.

Earlier today, FDA released an update to its outbreak investigation report, stating:

“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.”

The acknowledgment came just two days after CDC declared the outbreak to be at an end, and just three days after a spokesperson for FDA declined eFoodAlert’s request to identify the strain of Salmonella found during the agency’s inspection of the Kerry Inc. manufacturing facility in Gridley, Illinois.

Why the secrecy? Why the delay?

News of the outbreak first broke on June 14, 2018, with a voluntary recall announced by The Kellogg Company, and an outbreak investigation notice from FDA and CDC.

On July 26th, FDA released the text of a Warning Letter issued to Kerry Inc. pursuant to an inspection of the company’s Gridley, Illinois facility.

On July 31st, I submitted a Freedom of Information Act request to FDA for the inspection and lab reports on which the warning letter was based.

On September 25th, almost two months after making the request, I received the redacted reports. I immediately inquired as to why the specific Salmonella strain found inside the Kerry cereal production plant was redacted from the report. I was told, “The information you have received via foia is all we can provide at this time.” 

Why should this matter?

The Kellogg Company is not Kerry’s only customer.

As I reported three days ago, Kerry initiated its own voluntary recall on July 12th. The recall was not publicized. On July 16th, General Mills also issued an unpublicized recall for a Cheerios variety that contained an ingredient matching the description of the material recalled by Kerry.

According to a spokesperson for CDC, with whom I had an exchange of email messages in late August, no other cereals were linked to the outbreak. Nevertheless, many milder cases of salmonellosis always go unreported, especially by those who cannot afford a visit to the doctor or clinic.

There is no way of knowing whether anyone became infected as a result of eating the recalled General Mills cereal. And, in the absence of a public recall notice, US consumers were left ignorant of the risk.

Breakfast cereals, especially sweetened cereals, are consumed preferentially by children – one of the most vulnerable sectors of the population. In this instance, FDA put the ‘privacy’ concerns of Kellogg, Kerry, and other companies above its mandate to protect the public from contaminated food.

 

Recalls and Alerts: September 23 – 26, 2018

Here is today’s list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

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United States

OUTBREAK ALERT (UPDATE): FDA and CDC have declared the Salmonella Mbandaka outbreak associated with Kellogg’s Honey Smacks ready-to-eat breakfast cereal to be over. In all, 135 consumers in 36 states were infected with the outbreak strain. Thirty-four (34) people were hospitalized in an outbreak that lasted spanned six full months (March 1 – August 30, 2018).

Allergy Alert: Harris Teeter recalls Harris Teeter Low Fat Frozen Yogurt Cookies & Cream (1.5 qt laminated cartons; all SELL BY DATES up to 07/30/19; UPC 0 72036 98182 0) due to undeclared peanut.

Allergy Alert: Whole Foods Market recalls 365 Everyday Value White Corn Tortilla Chips Salted-Party Size (20-oz bags; Best-by dates between January 24-25, 2019; UPC 9948247145) due to undeclared milk.

Food Safety Recall: Mauna Loa Macadamia Nut Corporation recalls all of its products produced at the Keaau facility between Sept. 6 – 21, 2018 due to a potential contamination of Escherichia coli. The recall was initiated after E. coli was detected in the well water and distribution system that supplies the firm’s operations. Please refer to the recall notice for a complete list of affected products.

Canada

Allergy Alert: Whole Foods Market recalls 365 Everyday Value brand White Corn Tortilla Chips Salted (567 g; Best by dates between January 24-25, 2019; UPC 0 99482 47145 3) due to undeclared milk. The recalled product was distributed to retailers in Ontario.

Food Safety Recall: 3301861 Nova Scotia Limited recalls Cabot brand Oysters (75-count and 100-count; Harvest Date 16-09-2018; Packed on date 17-09-2018; Harvest Location 1387 (lease); No UPC) due to Salmonella contamination. The recalled product was supplied to consumers in Nova Scotia and Quebec and may have been distributed nationwide.

Food Safety Recall: Abbott Nutrition recalls Abbott Promote brand High-Protein Liquid Nutrition – Vanilla Flavour (235 ml; Product code L84417RA0 xxxx (xxxx=time code) 2019JA1; UPC 0 55325 20170 0) and Abbott Two Cal HN brand Complete, Balanced Nutrition – Vanilla (235 ml; Product codes L85559RA0 xxxx (xxxx=time code) 2019FE1 and L87139RA0 xxxx (xxxx=time code) 2019AL1; UPC 0 55325 20799 3) due to bacterial contamination. One illness has been reported. The recalled products were supplied to retailers nationwide.

Europe

Allergy Alert (Belgium): Icelandic Gadus recalls various salad products to due undeclared gluten. Please refer to the recall notice for a complete list of affected products.

Allergy Alert (France): La Société BRIENT recalls Brient brand Cervelas (10 slices/90g; Lot #000001286690; Best before 08/10/2018) due to undeclared egg and mustard.

Allergy Alert (France): La société Cité Marine recalls Auchan Le Poissonnier brand Filets de cabillaud façon fish & chips (Best before 29/09/2018) due to undeclared egg.

Allergy Alert (France): Auchan recalls Auchan le Traiteur brand Samoussas Poulet / Chicken Samosas (40g x 4; Lot #05734142; Best before 10/10/2018) due to undeclared allergens.

Allergy Alert (Germany): Peter Braun Fleisch & Wurst GmbH & Co. KG recalls Paprikaschinkenwurst with egg (Best before dates up to 10.10.2018) due to undeclared pistachios.

Allergy Alert (Netherlands): Vomar Voordeelmarkt recalls De Notenkraam Katjang Pedis (275g; Best before 12-01-2019; Lot #18-109011) due to undeclared wheat (gluten), egg and soy.

Allergy Alert (UK): Sainsbury’s recalls in store bakery all butter croissants (individual and 2-packs; All best before dates up to and including 26 September, 2018) because they contain almond filling which is not declared on the packaging.

Food Safety Recall (France): Casino recalls Casino brand Pizza Chorizo et Poivrons (450g; Best before 20/09/18 – 25/09/18 – 01/10/18 – 04/10/18) due to possible Listeria in the chorizo.

Food Safety Recall (France): Auchan recalls Gerblé sans gluten brand Pain aux graines (Lot #190119; Best before 19/01/19) due to foreign matter (metal pieces) contamination.

Food Safety Recall (Germany): Landhof “Am Ziegenried” GmbH recalls its entire range of cut cheeses due to possible Salmonella contamination. Please refer to the recall notice for a complete list of affected products.

Food Safety Recall (Ireland): Dr. Zak’s recalls Dr Zak’s Barn Farmed Liquid Egg White (pack size 970ml; Batch #18163BN2A, best-before 12/12/2018 – Batch #18180BN2B, best-before 29/12/2018 – Batch #18228BN2A, best-before 02/02/2019) due to Salmonella contamination.

Food Safety Recall (Luxembourg): Cora recalls Pizza Chorizo et Poivron (450g; Best before 20/09/2018,25/09/2018,01/10/2018,04/10/2018) due to Listeria contamination.

Australia and New Zealand

Allergy Alert (Australia): Europlus Pty Ltd recalls Mahroum Sesame Halva (400g; Best Before 31.12.2018) due to undeclared pistachio nuts.

Food Safety Recall (New Zealand): Premier Beehive NZ recalls Beehive brand Original sausages (1 kg; Batch #234234; Use by 17/10/18) due to foreign matter (metal) contamination.

Food Safety Recall (New Zealand): PAK’nSAVE Glen Innes recalls various PAK’nSAVE brand minced meats due to foreign matter (metal) contamination. Please refer to the recall notice for a detailed list of affected products.