Inspections, Compliance, Enforcement, and Criminal Investigations
East Wind Community, Inc 10/5/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Kansas City District
11630 West 80th Street
P.O. Box 15905
Lenexa, Kansas 66285-5905
Telephone: (913) 752-2100
October 5, 2009
RETURN RECEIPT REQUESTED
Ref. KAN 2010-01
Zeke L. Preis, President
East Wind Community, Inc.
HCR 3 Box 3370
County Road 547
Tecumseh, MO 65760-9503
Dear Mr. Preis:
On July 14-15, 2009 Investigators from the United States Food and Drug Administration (FDA) inspected your nut butter manufacturing facility located at County Road 547, Tecumseh, MO 65760. FDA laboratory analyses of environmental samples collected during this inspection found the presence of Salmonella. These analyses cause FDA to consider products manufactured at your facility to be adulterated within the meaning of Section 402(a)(4) of the Food, Drug, and Cosmetic Act (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."
During this inspection numerous environmental samples were collected throughout your facility from various surfaces. Seven of the environmental swabs tested positive for Salmonella spp. These positive samples were taken from seven different locations near both of your production lines. Serotyping of these samples found the specific Salmonella serotypes to be S. Java in one sample and S. Newport in six samples. Pulsed Field Gel Electrophoresis (PFGE) testing results showed five of the six S. Newport samples had identical PFGE patterns. This is significant because these five samples were located in five different locations in both production rooms indicating that S. Newport may have been transported throughout your production areas and established niche areas to colonize.
One of the six S. Newport serotypes had a PFGE pattern that was distinguishable from the other five. This sample was of particular concern because it was taken from the southeast wheel of the Capper of Production Line# (b)(4) on which caps are applied to seal open containers filled with ready-to-eat product. This close proximity increases the potential of contamination of the product with Salmonella.
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; on raw ingredients, particularly peanuts, tree nuts, and cocoa beans; and by rodent vectors. Once established on production area floors the organism can contaminate food and food-contact surfaces through either human or mechanical means.
You should take prompt and aggressive actions to eliminate the Salmonella contamination addressed in this letter. Failure to promptly correct this situation may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure and/or injunction. Also, federal agencies are advised of the issuance of all Warning Letters so that they may take this information into account when considering the award of contracts.
Please notify this office, within fifteen (15) working days of receiving this letter, of the steps you have taken to bring your firm into compliance with the law. Your response should include a description of the status of corrective actions taken to address the violations as well as detailed plans on how you will prevent the violations from recurring. If your planned corrective or preventive actions will occur over time, please include a timetable for implementation. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed.
Your reply to this Warning Letter should be sent to Matt Walburger, Compliance Officer, Food & Drug Administration, Kansas City District, Southwest Region, 11630 West 80th Street, Lenexa, Kansas 66214-3340. If you have any questions about the content of this letter, please contact Mr. Walburger at 913-752-2104.
John W. Thorsky
Kansas City District