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  5. Double Tree Dairy Farm, LLC - 510168 - 12/12/2016
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CLOSEOUT LETTER

Double Tree Dairy Farm, LLC MARCS-CMS 510168 — 12/12/2016

Double Tree Dairy Farm, LLC - 510168 - 12/12/2016


Recipient:
Recipient Name
Mr. William H. Wright
Double Tree Dairy Farm, LLC


Holden, UT 84636-0246
United States

Issuing Office:
Denver District Office

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
Denver District Office
6th Ave & Kipling Street
P.O. Box 25087
Denver, CO 80225 

 

December 12, 2016
 
WARNING LETTER
 
 
VIA UPS Overnight
 
Mr. William H. Wright, Owner
Double Tree Dairy Farm, LLC
P.O. Box 126
Holden, Utah 84636-0246
 
 
Ref: # DEN-17-01-WL
 
Dear Mr. Wright:
 
On September 21 and 23, 2016, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 3016 West 11700 North, Holden, Utah. 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 web 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 April 6, 2016, you sold a dairy cow, identified with back tag (b)(4) for slaughter as food. On or about April 7, 2016, (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 5.25 parts per million (ppm) of desfuroylceftiofur in the kidney tissue. FDA has established a tolerance of 0.4 ppm desfuroylceftiofur (marker residue for ceftiofur) in kidney tissue as codified in Title 21, Code of Federal Regulations (CFR), Section 556.113(b)(3)(i) (21 CFR 556.113(b)(3)(i)). The presence of this drug in edible tissues 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 held 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 and review said records to verify the applicable withdrawal time prior to offering the animal for slaughter as food. Your treatment records lacked information about the dosage given, route of administration, withdrawal time for meat and milk, and individual who administered the drug.  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).
 
We also found that you adulterated the new animal drug (b)(4) (ceftiofur (b)(4), NADA #(b)(4)). Specifically, our investigation revealed that you did not use this drug product as directed by its approved labeling because you did not follow the withdrawal time on the label prior to offering the animal for slaughter. Use of this drug in this manner is an extralabel use. See 21 CFR 530.3(a).   
 
Our investigation found that you administered (b)(4) to a dairy cow identified with back tag #(b)(4), without following the pre-slaughter withdrawal period as stated in the approved labeling. Specifically, per your own admission, you treated the cow identified with back tag #(b)(4) with (b)(4) and sold the animal three days prior to meeting the 13-day withdrawal period. Your (b)(4) extralabel use of (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a) and your extralabel use of (b)(4) resulted in an illegal drug residue, in violation of 21 CFR 530.11(d). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 CFR Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C 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.
 
We acknowledge receipt of your October 4, 2016 response to the FDA Form 483 issued to your firm on September 23, 2016. This response has been reviewed and has been determined to be inadequate to address our concerns as you have failed to provide details, dates for implementation, or documented examples for implemented corrective actions. For example, your response states the following: 1) A more thorough check of animal history [f]or cows going to slaughter; 2) Keeping a longer and more complete history of treatment events; and 3) Drug inventories, keep purchase records and invoices of medications purchased. We request that you clarify how long you intend to maintain treatment and purchase records, how they will be maintained, and who will be responsible for reviewing such records prior to sending cows for slaughter. In addition, we request that you clarify when your proposed corrective actions will be implemented and what type of information will be included in the treatment records that you define as “more complete”. 
 
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 Matthew R. Dionne, Compliance Officer, U.S. Food and Drug Administration, 6th Avenue & Kipling Street – Building 20 DFC, P.O. Box 25087, Denver, Colorado 80225-0087. If you have any questions about this letter, please contact Dr. Dionne at (303) 236-3064 or via email at Matthew.Dionne@fda.hhs.gov.
 
 
Sincerely,
/S/
LaTonya M. Mitchell
District Director
Denver District
  
 
cc:
Ms. Anna Gallegos, DM
1 Denver Federal Center
Bldg. 45, Door S3
 P.O. Box 25387
Denver, CO 80225
 
LuAnn Adams, Commissioner
Utah Dept. of Agriculture and Food
350 N Redwood Road
PO Box 146500
Salt Lake City, UT 84114-6500
 

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