Inspections, Compliance, Enforcement, and Criminal Investigations
WHB Cattle, LP (Braum Dairy Farms) 6/17/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
June 17, 2011
RETURN RECEIPT REQUESTED
Drew Braum, President and CEO
W.H. Braum, Inc.
3000 N.E. 63rd Street
Oklahoma City, OK 73121
Dear Mr. Braum:
On April 19 - 20, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation, WHB Cattle, LP, located at 17095 FM 3004, Follett, Texas 79034. 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 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 February 10, 2011, your firm sold a dairy cow, identified with ear tag (b)(4) for slaughter as food. On or about February 10, 2011, (b)(4) slaughtered this animal. United States Department of Agriculture, Food and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of Penicillin at 0.4 ppm in the kidney. A tolerance of 0.05 ppm has been established for residues of Penicillin in the edible tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.510 (21 C.F.R. § 556.510). 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 Act, [21 U.S.C. § 342(a)(2)(C)(ii)].
Our investigation also found that your firm holds animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, your firm failed to maintain complete treatment records. It was noted during your inspection that your firm's handwritten and electronic treatment records did not include drug dosage, route of administration, withdrawal time for meat and milk, and person administering the treatment. In addition, your firm's handwritten and electronic records conflict on last treatment date (January 21, 2011 and January 23, 2011) for the cow with ear tag (b)(4) 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)].
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 Ronda Loyd-Jones, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Ste. 300, Dallas, Texas 75204. If you have any questions about this letter, please contact Compliance Officer Ronda Loyd-Jones at 214-253-5242.
Reynaldo R. Rodriguez, Jr.
Dallas District Director
Winefredo E. Al-ag, Dairy Manager
WHB Cattle, LP
17095 FM 3004
Follett, Texas 79034