Kellogg was guilty of “significant deviations from the current Good Manufacturing Practice (CGMP) regulations” at its Eggo Buttermilk Waffle plant in Georgia, said the Food and Drug Administration (FDA) in it warning letter sent to the company on 27 January. The agency’s district controller in Atlanta also said that a reply received from Kellogg in November had failed to address the CGMP shortcomings.
The list of breaches included leaving uncovered rubbish just inches from raw materials, allowing potentially tainted water to drip onto food lines, and a number of unsatisfactory cleaning methods by employees.
“These violations and the results of the laboratory analyses cause the foods manufactured at your facility to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health”, said the federal body.
Listeria contamination
The FDA found Kellogg had flouted a series of food regulations after carrying out an inspection at the Bucknell Drive site in Atlanta on 22 October. The probe, launched after the Georgia Department of Agriculture (GDA) had detected Listeria Monocytogenes at the plant in August 2009, revealed the potentially deadly bacteria was present in more than one area of the facility.
The FDA confirmed that five environmental swabs had tested positive for Listeria. It added that Pulsed Field Gel Electrophoresis (PFGE) testing results determined that three of the environmental swabs had a PFGE pattern identical to the positive sample gathered by the GDA.
“This is significant because these three swabs were taken from three different locations in your facility and the swabs' indistinguishable PFGE pattern was found in your firm's finished product, Eggo Buttermilk Waffles,” said the FDA. “The PFGE results reveal that L. monocylogenes may have been transported throughout your facility and may have established niche areas to colonise.”
One of the contaminated samples was swabbed from the wheels of a forklift truck in the packaging area of the plant. The FDA said this was a particular concern “as the organism is likely to spread when the forklift moves throughout the facility”.
Hygiene breaches
The agency detailed four main violations, although it added the list may not be exhaustive. The first involved the use of high pressure water to clean equipment near exposed raw materials. Water splashing near the ingredient posed a contamination risk, it said.
The FDA also said Kellogg employees left uncovered trash six inches from exposed raw materials and food contact surfaces. Inspectors saw possibly contaminated condensate fall from pipes above onto exposed food on conveyor lines. Employees not wearing gloves were seen touching food and other unsatisfactory hygiene practices were also logged.
The agency further raised concerns about a response from Kellogg received on 18 November. While the FDA said it noted a list of corrective actions the company said it had made, it added that Kellogg had failed to address the CGMP deviations listed.
It also said Kellogg’s sanitation controls should include “effective environmental monitoring programs designed to identify and eliminate and/or control pathogens such as L. monocytogenes in and on surfaces and areas in the facility where contamination could result in food product contamination”