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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

WHB Cattle LLC

  

hhsbluebirdDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, TX 75204-3128
 

September 1, 2009

2009-DAL-WL-19

Certified Mail
Return Receipt Requested

WARNING LETTER 

William H. Braum, President and Owner
WHB Cattle, LLC
dba Braum Dairy Farms
County Street 491, Box 2880
Tuttle, Oklahoma 73089
 

Dear Mr. Braum:
 

On March 11, 2009 and June 19, 2009, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at County Street 491, Tuttle, Oklahoma. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on the 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 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 Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the 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 August 14, 2008, you sold a dairy cow identified with farm tag# (b)(4) for slaughter as food. On August 14, 2008, (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 (ceftiofur) in the kidney at 11.34 parts per million (ppm). FDA has established a tolerance of 0.4 ppm desfuroylceftiofur in the kidney of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.) 556.113(a)(3)(i) (21 C.F.R. 556.113(a)(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 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 is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4). 

We also found that you adulterated the new animal drug ceftiofur. Specifically, our investigation revealed that you did not use ceftiofur (b)(4) as directed by its approved labeling. Use of this drug in this manner is an extralabel use. 21 C.F.R. 530.3(a). 

The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the 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 ceftiofur sterile suspension (b)(4) 200mg/ml to a dairy cow without following the dosage or the withdrawal period 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). Your extralabel use of ceftiofur (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 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 Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the 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 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, 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 Compliance Officer Sherrie L. Krolczyk, 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, Sherrie L. Krolczyk at 214-253-5312 or SherrieKrolczyk@fda.hhs.gov. 

 

Sincerely,

/s/

Reynaldo R. Rodriguez, Jr. 

Dallas District Director 

RRR/sik 

cc: Larry L. Ricks, Jr., Dairy Manager
WHB Cattle, LLC (Braum Dairy Farms)
County Street 491, Box 2880
Tuttle, Oklahoma 73089
 


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