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  5. Elkins Dairy LLC - 01/22/2016
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WARNING LETTER

Elkins Dairy LLC Jan 22, 2016

Elkins Dairy LLC - 01/22/2016

Product:
Animal & Veterinary

Recipient:
Elkins Dairy LLC


United States

Issuing Office:
Cincinnati District Office

United States


   

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

Public Health Service
Food and Drug Administration
 
Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2775

 

January 22, 2016
 
 
Via United Parcel Service
 
 
Mr. Timothy K. Elkins, Co-owner
Mr. Chad Elkins, Co-owner
Mr. Bradley Elkins, Co-owner
Elkins Dairy, LLC
2699 Hays Pondsville Road
Smiths Grove, Kentucky 42171
 
Warning Letter
CIN-16-485226-07
 
Dear Messers Elkins:
 
On September 21,  23, 25 and October 9, 2015 the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 2699 Hays Pondsville Road, Smiths Grove, Kentucky. 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 July 7, 2015, you sold a dairy cow, identified with back tag (b)(4), for slaughter as food.  On or about July 9, 2015 (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 florfenicol at 0.28 parts per million (ppm) in the muscle tissue and 6.01 ppm in the liver tissue. FDA has not established a tolerance for residues of florfenicol in the edible tissues of dairy cows. 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 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 and properly dispose of expired drug products. 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 Nuflor Injectable Solution (florfenicol, NADA 141-063). Specifically, our investigation revealed that you did not use Nuflor as directed by its approved labeling or veterinary prescription. Use of this drug in this manner is an extralabel use. See Title 21, Code of Federal Regulations (C.F.R.), Section 530.3(a) (21 C.F.R. 530.3(a)). We have enclosed a copy for your reference.
 
The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C 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 Nuflor to a dairy cow identified with back tag (b)(4) without following the withdrawal period as stated in the approved labeling. Your extralabel use of Nuflor was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a), and resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c). 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 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. 
 
Our investigation also revealed that on or about July 21, 2009, you submitted a Certification of (b)(4) that states that the animals presented for slaughter do not have illegal levels of drug residues. On July 7, 2015, you delivered a dairy cow, which contained violative residues of florfenicol, from your farm to (b)(4). Providing such a false guaranty is prohibited by section 301(h) of the FD&C Act, 21 U.S.C. 331(h). You should take appropriate actions to ensure that this violation does not recur.
 
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 Allison C. Hunter, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, please contact Compliance Officer Hunter at 513-679-2700 X2134 or allison.hunter@fda.hhs.gov.
 
Sincerely yours,
/S/ 
Steven B. Barber
District Director
Cincinnati District
 
 
cc:     Dr. Isabella Arrington
         United States Department of Agriculture (USDA)
         Food Safety and Inspection Service (FSIS)
         Landmark Center, Suite 300
         1299 Farnam Street
         Omaha, Nebraska 68102
 
         Dr. Roger C. Thomas, DVM
         Thomas Veterinary Services PLC
         156 Vincent Street
         Smiths Grove, KY 42171