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WARNING LETTER

Spurlock Farms MARCS-CMS 443065 —


Delivery Method:
Overnight Mail
Product:
Animal & Veterinary

Recipient:
Recipient Name
Jewel B. Spurlock
Spurlock Farms

1205 E. Side Road

Judsonia, AR 72081-9407
United States

Issuing Office:
Dallas District Office

United States


 

   

Black HHS-Blue FDA Logo

 

Dallas District Office
4040 North Central Expressway
Suite 300
Dallas, Texas 75204-3128 

 
 

January 9, 2015

2015-DAL-WL-10

WARNING LETTER

UPS OVERNIGHT MAIL

Jewel B. Spurlock, Owner
Spurlock Farms
1205 E. Side Road
Judsonia, Arkansas 72081-9407

Dear Mr. Spurlock:

On August 15 and 18, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your cattle raising operation located at 1205 E. Side Road, Judsonia, Arkansas 72081-9407. This letter notifies you of the violations to 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 11, 2014, you sold a Charolais bull identified with ear tag #(b)(4) and back tag #(b)(4) for slaughter as food. On or about March 12, 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 0.66 parts per million (ppm) of desfuroylceftiofur (marker residue for ceftiofur) in the kidney tissue. FDA has established a tolerance of 0.4 ppm for residues of ceftiofur in the kidney tissue) of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113. 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 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. Food from animals held under such conditions are 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 hydrochloride sterile suspension, NADA #(b)(4)). Specifically, our investigation revealed that you did not use (b)(4) as directed by its approved label or by the servicing veterinarian's prescription. Use of this drug in this manner is an extralabel use. See 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 (b)(4)(ceftiofur hydrochloride sterile suspension, NADA #(b)(4)) to your Charolais bull identified with an ear tag (b)(4)# and back tag #(b)(4) (#(b)(4)) without following the withdrawal time set forth in the approved product 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 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 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 January 14, 2014, you provided (b)(4) located in (b)(4), with a signed "Livestock Seller Continuous Country of Origin Affidavit/Declaration" stating that none of the cattle delivered to the auction have an illegal level of drug residue. This signed certificate, which remains in effect until revocation is delivered to (b)(4), covered the cow identified with ear tag #(b)(4) and back tag #(b)(4), which was found to contain a violative desfuroylceftiofur residue. 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.

We acknowledge your written response, dated August 19, 2014, to the Form FDA 483 that was issued to you at the close of the inspection. Your response stated you have taken steps to assure that a residue does not happen again; you will not bring any animals to any sale barn unless you have observed the withdrawal time for the medication; and you have explained to your employees that you wm begin keeping better records of culls and sales using a form that includes all the necessary information, and retaining the records after the animal leaves the herd. However, we cannot verify this corrective action for effectiveness at this time.

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 Rose M. Ashley, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about this letter, please contact Compliance Officer Rose M. Ashley at (210) 308-1407.

Sincerely,
/S/
Reynaldo R. Rodriguez, Jr.
Dallas District Director
 

cc:

J. Wesley Benton, Cattle Manager
Spurlock Farms
1205 E. Side Road
Judsonia, Arkansas 72081-9407

Texas Department of State Health Services
Attn: Lewis Ressier
Food Program Manager
Exchange Building
8407 Wall Street
Austin, Texas 78754

FSIS District Office 40
Attn: Dr. Beasley-McKean
District Manager
1100 Commerce Street, Room 516
Dallas, Texas 75242-0598