The FDA has finally confirmed that Kerry Inc. manufactured the Kellogg’s Honey Smacks traced to a Salmonella Mbandaka outbreak that sickened people across 36 states. Documents show the manufacturer knew its plant and cereal produced there were contaminated with Salmonella before the outbreak.
In August federal officials released a warning letter they sent in July to Kerry CEO Michael O’Neill. That warning cited long-term Salmonella contamination in the company’s production plant in Gridley, IL. However, the Food and Drug Administration blacked out key words and phrases regarding specific products in that July 26 warning.
With the Sept. 28 statement from FDA, consumers no longer have to guess where the implicated Honey Smacks became contaminated.
“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,” according to the update posted Friday.
“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 day before the FDA’s update Sept. 28 update, the Centers for Disease Control and Prevention declared the Salmonella outbreak over. The agency reported 135 people had been confirmed with infections. Of the 101 patients for whom the information was reported, 34 required hospitalization. Public health officials did not report any deaths among the confirmed cases.
Public health officials remain concerned that consumers may have the recalled Honey Smacks cereal in their homes. They urge the public to check for the cereal and immediately throw it away if they have any of it.
Lab samples CDC and FDA collected from patients, cereal from their homes, cereal from retailers, cereal at the Kerry plant and from the plant itself were all positive for Salmonella.
Kerry Inc. is a multinational company based in Ireland. It registered its Beloit, WI, operation in August 1993 with the Wisconsin Secretary of State. The company is registered as a “foreign business corporation” with a foreign organization date of Oct. 5, 1983. Wisconsin records show “paid capital represented” of $7.6 million. It previously did business in Wisconsin under the names Kerry Ingredients Co. and Kerry Foods Inc.
As of Sept. 28, the Kerry Inc. website’s news and media pages were not operational. It appeared the company did not have any information about the outbreak or the FDA’s investigation at the Gridley, IL, production plant. However, an external public relations company distributed a statement on the evening of the 28th that was attributed to “Kerry Foods.”
“Kerry has a long history of meeting or exceeding the highest standards of the food industry, and for employing robust preventive control procedures to ensure the complete safety of our products. We regret that we experienced gaps in implementing controls,” according to statement.
The Kerry company officials expressed appreciation for the FDA inspection and subsequent findings, which were detailed in the July warning letter. They said they developed a corrective plan as a result of the FDA’s action, saying they are “fully committed to implementing the corrective measures the FDA has recommended.”
Those measures, as outlined in the company statement, include:
- A full review of the facility and implementation of changes to hygienic zoning and traffic control programs;
- Updated environmental monitoring program;
- Re-engineered certain equipment to improve its sanitary design; and
- Enhanced training and auditing to ensure programs are implemented as written.
“We value the agency’s careful attention to operations following this recall, as the close inspection of our procedures and practices provides us with a valuable opportunity to further strengthen our food safety programs and their implementation,” according to the Kerry statement.
The Sept. 28 commitment from Kerry Inc. to implement new food safety procedures was not the first time company officials said they would resolve violations of federal food safety laws.
The FDA inspected the company’s Wisconsin production plant June 14-29. Test results from that inspection showed Salmonella contamination in the facility. Inspectors found company documents showing that it had conducted its own testing, finding Salmonella repeatedly in its plant from September 2016 forward. The company also had records showing it has found Salmonella in cereal it had produced.
In response to that inspection and the subsequent report FDA sent the company, Kerry Inc. officials hired a third-party consultant and promised to change written procedures and plans for finding and eliminating pathogens. The FDA stressed in its July warning letter that the company had failed to act for at least 18 months before the agency’s June inspection.
“Between Sept. 29, 2016, and May 16, 2018, you repeatedly found Salmonella throughout your facility, including in cereal production rooms. During this time period, you had 81 positive Salmonella environmental samples and 32 positive Salmonella vector samples — samples taken in response to finding a positive on routine testing — including four Salmonella (redacted) samples in the cereal coating room (Line redacted) and one Salmonella redacted sample in the cereal (cereal name redacted) room (Line redacted),” the FDA warning letter stated.
“Further, you had repeated findings of other Salmonella species in some production lines and rooms used for the manufacture of cereal. These repeated findings of Salmonella in your environment should have resulted in a reanalysis of your food safety plan as required by 21 CFR § 117.170(b)(4) and the identification of contamination of RTE cereal with environmental pathogens as a hazard requiring a preventive control, i.e., sanitation preventive control.”