This is just too good not to print in full:

January 27, 2010

VIA FEDERAL EXPRESS

A.D. David Mackay, President & CEO

Kellogg Company
1 Kellogg Square
Battle Creek, MI 49017

WARNING LETTER
(10-ATL-07)

Dear Mr. Mackay:On October 22-29, 2009, the U.S. Food and Drug Administration (FDA) conducted an inspection of your frozen food manufacturing facility located at 5601 Bucknell Drive, SW, Atlanta, GA 30336. The inspection was initiated in response to a notification from the Georgia Department of Agriculture (GDA) on August 31, 2009, of a positive test for Listeria monocytogenes in your Eggo Buttemilk Waffles identified with a Better If Used Before date beginning with NOV17 10 EAAM1. During the inspection, we collected a variety of samples consisting of finished products, in-process products, and environmental swabs. FDA laboratory analyses of the environmental swabs collected during this inspection also found the presence of the pathogen Listeria monocytogenes in your facility. In addition, we found that you have significant deviations from the current Good Manufacturing Practice (CGMP) regulations for food manufacturers, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). 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) [21 U.S.C. § 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act and FDA’s regulations through links in FDA’s home page at http://www.fda.gov.

Listeria monocytogenes (L. monocytogenes) is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility. L. monocytogenes can contaminate foods, resulting in a mild illness (called listerial gastroenteritis) or a severe, sometimes life-threatening, illness called invasive listeriosis. Listeriosis is an atypical foodborne illness of major public health concern because of the severity of the disease, a high case-fatality rate, a long incubation and a predilection for individuals with underlying conditions.

During the FDA inspection, investigators collected environmental samples from various areas in your facility. Five environmental swabs tested positive for L. monocytogenes. Pulsed Field Gel Electrophoresis (PFGE) testing results determined that three of the environmental swabs had a PFGE pattern that was indistinguishable from the positive sample collected 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. The PFGE results reveal that L. monocylogenes may have been transported throughout your facility and may have established niche areas to colonize. One of the aforementioned environmental swabs was taken from the wheels on a forklift observed in the packaging area. The presence of L. monocylogenes on the wheels of a forklift is a concern as the organism is likely to spread when the forklift moves throughout the facility.

Two of the positive environmental swabs had PFGE patterns that were distinguishable from the other three environmental swabs and the positive sample collected by the GDA. One of these samples was collected from the floor at the walk-through door to the battery changing room. The other sample was collected from the bottom of a grey tote located at the end of the (b)(4) conveyor.

Bacteria may enter and/or be transported through a food plant by a variety of routes that include, but are not limited to: roof leaks; the shoes of employees, contractors, and visitors; the wheels of fork lifts, pallet movers, and moveable equipment; soiled pallets; soiled raw material packaging; raw ingredients; and by rodent vectors. Once established on production area floors, the pathogen may contaminate food and food-contact surfaces through either human or mechanical means. L. monocylogenes differs from most other foodborne pathogens because it is widely distributed, resistant to diverse environmental conditions, including low pH and high NaCl concentrations, and grows under refrigeration conditions.Continue Reading FDA Letter Hits Kellogg for Multiple Food Safety Violations

Recall Release CLASS I RECALL
FSIS-RC-004-2010 HEALTH RISK: HIGH

Editor’s Note: This recall release is being reissued to expand the January 18 recall to include approximately 4.9 million additional pounds of beef and veal products, and to correct net weights from 40 lbs. to 50 lbs. in five instances in the earlier release.

Huntington Meat…