WARNING LETTER
Veenstra Dairy #1 Jun 23, 2014
Veenstra Dairy #1 - 06/23/2014
- Product:
- Animal & Veterinary
- Recipient:
- Veenstra Dairy #1
United States
- Issuing Office:
- Seattle District Office
United States
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Public Health Service Food and Drug Administration |
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Seattle District
Pacific Region
22215 26th Ave SE, Suite 210
Bothell, WA 98021-4425
Telephone: 425-302-0340
FAX: 425-302-0402
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Department of Health and Human Services
June 23, 2014
OVERNIGHT DELIVERY
SIGNATURE REQUIRED
In reply refer to Warning Letter SEA 14-15
Frank W. Veenstra, Owner
Veenstra Dairy Number 1
2675 South 1300 East
Hagerman, Idaho 83332-5847
WARNING LETTER
Dear Mr. Veenstra:
On April 8 and 10, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 2675 South 1300 East, Hagerman, Idaho. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the internet through links on FDA’s webs page at www.fda.gov.
We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the FD& C 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 FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C 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 November 5, 2013, you sold a dairy cow, identified with sales tag (b)(4), for slaughter as food. On or about November 5, 2013, (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 ampicillin at 0.1 parts per million (ppm) in the kidney tissue. FDA has established a tolerance of 0.01 ppm for residues of ampicillin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.40 (21 C.F.R. 556.40). The presence of this drug in uncooked 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 FD&C 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 treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C 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 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.
FDA acknowledges your firm’s written response dated April 28, 2014, addressing the observations made during the inspection we conducted at your firm. Although your letter indicates that your firm has taken steps to address our observations, your response is partially adequate. Your response did not provide completed treatment records, did not state if you implemented a procedure for tracing animals sent for slaughter, or how you will monitor the expiration dates of medications used by your facility to assure that expired medications are not being used on the animals.
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 Patricia A. Pinkerton, Compliance Officer, U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021-4425. If you have any questions about this letter, please contact Compliance Officer Patricia Pinkerton at (425) 302-0428.
Sincerely yours,
/S/
Miriam R. Burbach
District Director
cc: Jacob J. Blom, Foreman
Veenstra Dairy Number 1
2675 South 1300 East
Hagerman, Idaho 83332-5847
cc: Debra M. Lawrence, D.V.M.
Idaho State Department of Agriculture
Division of Animal Industries
P.O. Box 7249
Boise, Idaho 83707