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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Viacres L.L.L. and Natural Milk L.L.C. 01-Sep-08

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483-4996


 

July 15, 2008

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Viacres L.L.C. and Natural Milk L.L.C
Jerald D. Visser, Co-owner
5881 Jones Road
Sumas, Washington 98295
 

Jeremy D. Visser, Co-owner
5419 Hillview Road
Sumas, Washington 98295
 

In reply refer to Warning Letter SEA 08-27

WARNING LETTER

Dear Messers Visser:

Between May 7 and May 27, 2008, the U.S. Food and Drug Administration (FDA) conducted an investigation of your two dairy operations located at 5885 Jones Road, Sumas, Washington (Viacres L.L.C.) and 2305 Norman Road Stanwood, Washington(Natural Milk L.L.C.). This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operations. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.

We found that you offered for sale animals for slaughter as food that were adulterated. Under section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious-to health.

Specifically, our investigation revealed that on or about February 1, 2008, you consigned a dairy cow(delivered from Viacres L.L.C.), identified with back tag [redacted] for slaughter as food. On or about February 1, 2008, [redacted], slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of sulfadimethoxine at 6.47 parts per million (ppm) in the muscle tissue and 5.40 ppm in the liver tissue. FDA has established a tolerance of 0.1 ppm for residues of sulfadimethoxine in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Section 556.640 (21 C.F.R. 556.640). In addition, USDA/FSIS analysis of tissue samples collected from that same animal, identified the presence of flunixin at 0.20 ppm in the liver tissue. FDA has established a tolerance of 0.125 ppm for residues of flunixin in the edible tissues of cattle as codified in 21 C.F.R. 556.286.

In addition, our investigation revealed that on or about February 25, 2008, you sold a dairy cow (delivered from Natural Milk L.L.C.), identified with back tag [redacted] for slaughter as food. On or about February 26, 2008, [redacted] slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of sulfadimethoxine at 7.73 ppm in the muscle tissue and 4.12 ppm in the fiver tissue. FDA has established a tolerance of 0.1 ppm for residues of sulfadimethoxine in the edible tissues of cattle as codified in 21 C.F.R. 556.640.

Furthermore, our investigation revealed that on or about March 28, 2008, you consigned a dairy cow (delivered from Viacres L.L.C.), identified with back tag [redacted] for slaughter as food. On or about March 28, 2008, [redacted] slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of sulfadimethoxine at 0.41 ppm in the muscle tissue and 0.42 ppm in the liver tissue. FDA has established a tolerance of 0.1 ppm for residues of sulfadimethoxine in the edible tissues of cattle as codified in 21 C.F.R. 556.640.

The presence of sulfadimethoxine and flunixin in edible tissues from these animals in these amounts causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii).

Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain complete treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).

The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as 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 without further notice such as seizure and/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 of receiving this letter, 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.

Your written response should be sent to Michael J. Donovan, Compliance Officer, U.S. Food and Drug Administration, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have any questions about this letter, please contact Mr. Michael Donovan at (425) 483-4906.
 

Sincerely,
 

/S/
 

Charlee Breen
District Director
Seattle District
 

cc: FSIS District Office Western Regional Manager
620 Central Avenue. Building 2B
Alameda, California 94501

Washington State Department of Agriculture
Food Safety Program
1111 Washington Street
Olympia, Washington 98406