Coldstream Farms L.L.C. 6/21/10

Department 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

June 21, 2010

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

In reply refer to Warning Letter SEA 10-24

Jeff A.Rainey, Manager/Member

Coldstream Farms, L.L.C.

2304 Valley Highway

Deming, Washington 98244

WARNING LETTER

Dear Mr. Rainey:

On March 29 and 31, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 2304 Valley Highway, Deming, Washington. 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 operation. 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 July 8, 2009, you sold a dairy cow, identified with back tag (b)(4) for slaughter as food. On or about July 8, 2009, (b)(4), 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 penicillin in the kidney at 0.39 parts per million (ppm). FDA has established a tolerance of 0.05 ppm for residues of penicillin in the uncooked edible tissues of cattle, as codified in Title 21, Code of Federal Regulations, Section 556.510 (21 C.F.R. 556.510). The presence of this drug in edible tissue from this animal in this amount 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).

In addition, on our about November 19, 2009, you sold a dairy cow, identified with back tag (b)(4) for slaughter as food. On or about November 19, 2009, (b)(4) slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of flunixin in the liver at 0.3279 ppm. FDA has established a tolerance of 0.125 ppm for residues of flunixin in the liver tissues of cattle, as codified in 21 C.F.R. 556.286. The presence of flunixin in the liver tissue from this animal in this amount 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).

We also found that you adulterated the new animal drug penicillin. Specifically, our investigation revealed that you did not use Penicillin Injection (Penicillin G Procaine Injectable Suspension), NADA 065-010, as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See 21 C.F.R. 530.3(a).

The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.

Our investigation found that you administered Penicillin Injection (Penicillin G Procaine Injectable Suspension), NADA 065-010, to a dairy cow without following the approved indication for use, dose, and injection site limitation. Your extralabel use of Penicillin Injection (Penicillin G Procaine Injectable Suspension), NADA 065-010, was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of this drug resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the Act, 21 U.S.C. § 351(a)(5).

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 violations described in this letter and to establish procedures to ensure that these 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 Lisa M. Althar, 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 Compliance Officer Lisa M. Althar at (425) 483-4940.

Sincerely,

/s/

Charles M. Breen

District Director

 

cc: Galen D. Smith, Member Coldstream Farms, L.L.C.

2304 Valley Highway

Deming, Washington 98244

Washington State Department of Agriculture

Food Safety Program

P.O. Box 42560

Olympia, Washington 98504-2560

 

 

 

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