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  5. West Hope Dairy, LLC - 02/03/2015
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WARNING LETTER

West Hope Dairy, LLC

Product:
Animal & Veterinary

Recipient:
West Hope Dairy, LLC


United States

Issuing Office:
Baltimore District Office

United States


   

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

Public Health Service
Food and Drug Administration
  Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
FAX: (410) 779-5707 

WARNING LETTER
CMS# 448366

February 3rd, 2015
 

Via UPS

Mr. West H. Fint, Owner/Operator
West Hope Dairy, LLC
1364 Cedar Branch Road
Saltville, Virginia 24370

Dear Mr. Fint:

On December 2, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 1364 Cedar Branch Road, Saltville, Virginia. 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 March 5, 2014, you sold a dairy cow identified with ear tag (b)(4) to be slaughtered as food. On or about March 5, 2014, (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 9.04 parts per million (ppm) of desfuroylceftiofur (marker residue for ceftiofur) in the kidney. FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur in the uncooked edible kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113(b)(3)(i) (21 C.F.R. 556.113(b)(3)(i)). The presence of this drug in this amount in edible tissue from this animal cause 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 you fail to maintain a drug inventory system. 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 drug (b)(4), ceftiofur crystalline free acid). Specifically, our investigation revealed that you did not use (b)(4) 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 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 (b)(4) without following the indications for use as stated in the approved labeling. Your extralabel use of (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of (b)(4) 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 the 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.

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 David P. Rice, Compliance Officer, U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. If you have any questions about this letter, please contact Compliance Officer David P. Rice at (410) 779-5463 or e-mail at david.rice@fda.hhs.gov.
 

Sincerely yours,

/S/
Theresa Smedley
Acting District Director
Baltimore District

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