Dallas District Office
4040 North Central Expressway
Dallas, Texas 75204
February 8, 2017
UPS OVERNIGHT MAIL
Tyler M. Kamp, Co-Owner
Fred Kamp, Co-Owner
RR 1 Box 365
Laverne, Oklahoma 73848
Dear Messrs. Kamp and Kamp:
On June 22-24, 2016, the U.S. Food and Drug Administration (FDA) conducted an inspection of your beef cattle operation located at RR 1 Box 365, Laverne, Oklahoma 73848. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) 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 inspection revealed that on or about April 12, 2016, you sold a steer, identified with back tag (b)(4) for slaughter as food. On or about April 13, 2016, (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 Flunixin in the liver (target tissue) at 1.64 parts per million (ppm). FDA has established a tolerance of 125 parts per billion (ppb) (0.125 ppm) for residues of Flunixin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.286(b)(1)(i) (21 C.F.R. § 556.286(b)(1)(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 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).
On July 5, 2016, we received your response dated June 30, 2016 to the FDA 483, Inspectional Observations. We acknowledge your pledge to adhere to the Act, but our review found your response to be inadequate. Specifically, the treatment records you supplied are deficient in that they do not contain the route of administration or medication withdrawal time.
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 S. Alexander Hamblin, Compliance Officer, U.S. Food and Drug Administration, Dallas District Office, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about this letter, please contact Compliance Officer S. Alexander Hamblin at 214-253-5240.