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WARNING LETTER

CLA-COR Farms LLC MARCS-CMS 483436 —

Product:
Animal & Veterinary

Recipient:
CLA-COR Farms LLC


United States

Issuing Office:
Kansas City District Office

United States


   

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

Public Health Service
Food and Drug Administration
  Southwest Region
Kansas City District
8050 Marshall Drive
Suite 205
Lenexa. Kansas 66214-1524
913-495-5100
 

December 7, 2015
 

VIA UPS


WARNING LETTER
Ref. CMS# 483436


Mr. Dallas K. Cornelius, Co-Owner
Mrs. Debra A. Cornelius, Co-Owner
Mr. Isaiah A. Clayton, Co-Owner


CLA-COR Farms, LLC
2700 State Route Z
Easton, Missouri 64443


Dear Mr. Cornelius, Mrs. Cornelius and Mr. Clayton:
 

On October 13, 14, and 15, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 2700 State Route Z, Easton, Missouri. 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 September 1, 2015, you sold a culled dairy cow identified with yellow ear tag #(b)(4) for slaughter as food. On or about September 1, 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 desfuroylceftiofur (marker residue for ceftiofur) at 1.31 parts per million (ppm) in the kidney. FDA has established a tolerance of 0.4 ppm for residues of ceftiofur in the uncooked edible tissues 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 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 adequately maintain and retain complete 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).

We also found that you adulterated the new animal drugs Spectramast LC (ceftiofur hydrochloride, NADA #141-238) and Excede (ceftiofur crystalline free acid, NADA 141-209). Specifically, our investigation revealed that you did not use Spectramast LC and Excede as directed by their approved labeling or by the servicing veterinarian's prescription. Use of these drugs 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 Spectramast LC to dairy cows identified with ear tag #(b)(4) and ear tag #(b)(4) without following the duration of use set forth in the approved product labeling. Your extralabel use of Spectramast LC was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11 (a). Our investigation also found that you administered Excede to a dairy cow identified with ear tag 2261 without following the withdrawal time as set forth in the approved product labeling. Your extra label use of Excede was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11 (a) and your extralabel use of Excede resulted in an illegal residue, in violation of 21 C.F.R. 530.11(d). Ceftiofur hydrochloride is prohibited for extra label use in food producing animals by 21 C.F.R. 530.41(a)(13)(ii) . Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drugs 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 office is in receipt of your letter dated October 28, 2015 addressing the deviations noted on the Form FDA 483, lnspectional Observations, issued at the close of the inspection dated October 15, 2015. We have reviewed your response and find the corrective actions, in general, to be inadequate, as the response does not provide any representative documentation supporting your corrective actions and it does not address all deviations noted on the Form FDA 483.

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 response should be directed to: Andrew A. Hoopes, Compliance Officer, U.S. Food and Drug Administration, Kansas City District Office, 210 Walnut St., Suite 369, Des Moines, Iowa 50309. If you have any questions about this letter, please contact Compliance Officer Hoopes at (515) 244-0480 ext. 1002 or send him an email at andrew.hoopes@fda.hhs.gov.

Sincerely,
/s/
Cheryl A. Bigham
District Director
Kansas City District Office

 

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