| Public Health Service Food and Drug Administration |
| Atlanta District Office 60 Eighth Street, N.E. Atlanta, GA 30309 Telephone: 404-253-1200 FAX: 404-253-1201 |
Department of Health and Human Services
June 07, 2011
VIA UPS
John Bryant, CEO
Kellogg Company
1 Kellogg Square
Battle Creek, MI 49017
WARNING LETTER
(11-ATL-12)
Dear Mr. Bryant:
On February 07 – 10, 2011, investigators from the United States Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility located at 1550 Marvin Griffin Rd., Augusta, GA 30903. During the inspection we collected a variety of samples consisting of finished products and environmental swabs. FDA laboratory analyses of the environmental swabs (sample numbers 640160 and 640161) collected during this inspection found the presence of the pathogen Listeria monocytogenes (L. monocytogenes) in your facility, including on food contact surfaces. In addition, during our inspection we found that you have significant violations of the Current Good Manufacturing Practice (CGMP) regulations for food manufacturers, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). Based on these violations and on the results of the laboratory analyses of the environmental swabs collected during the inspection, we have determined that the foods manufactured at your facility are 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 have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or 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.
During the inspection environmental samples were collected throughout your facility. Fifteen of these environmental swabs were positive for the pathogen Listeria monocytogenes (L. monocytogenes). Seven of these positive environmental swabs were taken from direct food-contact surfaces which include the conveyor mesh and belt of the spiral cooler in production line (b)(4); the conveyor prior to the spiral cooler in production line (b)(4); and areas on the conveyor mesh and belt and from between the belt and wash catch pan of the spiral cooler in production line (b)(4). Analysis using Pulsed Field Gel Electrophoresis ("PFGE") showed that L. monocytogenes isolates obtained from the FDA environmental samples collected from your facility on February 07 and 08, 2011, were indistinguishable by both a primary and secondary enzyme; the observed PFGE pattern was also indistinguishable with isolates from environmental samples collected by FDA at your facility in January 2010. When a PFGE pattern of an isolate is indistinguishable from the pattern of another isolate from a common source, it is highly likely that two isolates are the same strain of L. monocytogenes. These PFGE results suggest that L. monocytogenes may have been transported throughout your facility and established in niche areas.
The presence of a persistent strain of L. monocytogenes in your facility between January 2010 and February 2011 is significant in that it demonstrates that your cleaning and sanitation efforts were inadequate to remove this organism. We note that although your finished product cookies may not support the growth of L. monocytogenes, the positive environmental swabs are indicators of insanitary conditions in your facility and demonstrate a failure of cleaning and sanitation operations that may allow for contamination of foods with filth or pathogens.
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 various pest vectors. Once established on production area floors the organism can contaminate food and food-contact surfaces through either human or mechanical means.
FDA investigators also observed the following violations of the CGMP regulation for foods (21 CFR 110):
1. Under 21 CFR 110.20(b)(4), your plant and facilities must be constructed in such a manner that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials. On February 08, 2011, our investigators observed the following:
- Multiple pipes were wrapped with material/insulation that appeared to be saturated with condensation.
- Pooling water due to drips from condensate was observed above mixers (b)(4), behind an unwelded splash guard; the pooled condensate was observed dripping directly into an open upright mixer bowl.
- Pooling water was observed below the in-feed of spiral cooler (b)(4).
- Pooling water was observed at the in-feed of spiral cooler (b)(4); the pool had a build-up of product debris and a black substance.
- Pooling water was observed in spiral cooler (b)(4) on the southwest corner below the mesh conveyor.
Your response dated March 09, 2011, outlines corrective actions such as removal of insulated piping with condensation or saturation, and other steps taken to minimize the potential for condensate drip. In addition, your “Augusta Hygienic Reset” document dated November 2010 and revised on February 08, 2011, outlines specific corrective actions (including leak diverters/condensation mitigation, (b)(4) duct relocation, floor repairs including sloping of floors to drains, and roof improvements) that appear to adequately address our concerns about future water pooling problems. However, your written response and Augusta Hygienic Reset document do not provide dates for completion for all of these projects. We will verify the adequacy and implementation of these corrections during our next inspection.
2. Under section 21 CFR 110.35(c), effective measures shall be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. On February 08, 2011, our investigators observed the following:
- Approximately twenty flies were observed exiting a drain located near spiral cooler (b)(4) and making contact with food contact surfaces.
- Approximately thirty flies were observed swarming in proximity of the flour sock of mixer (b)(4).
- Approximately eighty flies were observed after the back panel of mixer (b)(4) was removed.
Your response dated March 09, 2011, outlines corrective actions including detailed cleaning and fogging activities, including the use of a pressurized aerosol insecticide (b)(4) in the plant. We will evaluate the implementation and effectiveness of these corrective actions at our next inspection. In addition to improving cleaning and sanitation, FDA recommends fumigation to eliminate insects in the processing facility, and that your firm conduct a root cause analysis to address the potential source and/or attractant for insects or pests in your facility.
In addition to the March 09, 2011, response discussed above and the Augusta Hygienic Reset document discussed above, we acknowledge receipt of your firm’s response letters dated February 23, 2011, and March 02, 2011. Furthermore, on March 03, 2011, management representatives from Kellogg met with representatives of the Atlanta District Office and provided an overview of the corrective actions outlined in the March 02 response letter. FDA officials again met with representatives from your firm on May 02, 2011, at FDA’s White Oak campus in Silver Spring, Maryland to discuss food safety issues, and actions your firm has taken since FDA’s inspection in February 2011. We have evaluated your written responses and will verify the adequacy and implementation of these steps during our next inspection.
This letter is not an all-inclusive list of violations that may exist at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and applicable regulations. You should take prompt action to correct all of the violations noted in this letter and to establish and implement procedures that will prevent such violations from occurring in the future. Failure to implement lasting corrective action may result in FDA taking regulatory action, such as seizure or injunction, without further notice.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Your reply to this Warning Letter should be sent to Derek C. Price, Compliance Officer, Food and Drug Administration, 60 Eighth Street, NE., Atlanta, GA 30309. If you have any questions about the content of this letter, please contact Mr. Price at 404-253-2277.
Sincerely,
/S/
John Gridley
District Director
Atlanta District Office
cc: Mr. Keith Downing, Plant Manager
Kellogg Company
1550 Marvin Griffin Rd
Augusta, GA 30903
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