Inspections, Compliance, Enforcement, and Criminal Investigations
Dee Creek Farm 02-May-06
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 06-26
Michael E. Puckett and Anita C. Puckett
Dee Creek Farm
P.O. Box 1936
Woodland, WA 98674-1800
Dear Mr. and Mrs. Puckett:
An inspection of your dairy operation, located at 2404 Little Kalama River Road, Woodland, Washington, was conducted by representatives of the U.S. Food and Drug Administration (FDA) on December 16, 2005, as part of an investigation of a food borne illness outbreak in Southwest Washington and Northwest Oregon.
Our inspection determined that your dairy farm caused to be delivered into interstate commerce unpasteurized milk, in finished form for human consumption. Such distribution is a violation of the Public Health Service Act (PHS Act), 42 U.S.C. § 271(a), and the regulation codified in Title 21, Code of Federal Regulations (CFR), section 1240.61(a). The regulation bans, among other things, delivering into interstate commerce milk and milk products in final package form for direct human consumption unless they have been pasteurized. Your cow's milk is "milk" as that term is defined by 21 C.F.R. § 131.110. Further, your milk, which you cause to be shipped into interstate commerce is in final package form for direct human consumption. For your information, we have enclosed a copy of the regulation as it was published in the Federal Register, 52 FR 29509 (August 10, 1987).
Additionally, the public health officials of the Oregon Department of Human Services have advised FDA that Dee Creek's unpasteurized milk was responsible for a December 2005 outbreak of E. coli 0157:H7 in Washington and Oregon. The evidence regarding the outbreak shows that your milk contained E. Coli 0157:H7. As such, your unpasteurized milk was adulterated within the meaning of section 402(a)(1), 21 U.S.C. § 342 (a)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act), in that the milk contained a poisonous or deleterious substance that rendered it injurious to health.
The above is not intended to be an all-inclusive list of violations. As a producer of food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.
You should take prompt action to correct the above violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action, such as a seizure or injunction.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Please send your written reply to the Food and Drug Administration, Attention: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you have any questions regarding this letter, please contact Mr. Donovan at (425) 483-4906.
Charles M. Breen