May 4, 2016
CMS Case 495556
DELIVERY VIA UPS
Corey L. Kay, Owner
Corey L. Kay Farm
1171 Road 15
Coldwater, KS 67029-5662
Dear Mr. Kay:
The U.S. Food and Drug Administration (FDA) inspected your cattle production operation located at
1171 Road 15 in Coldwater, KS on 3/30-4/1/16. 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 FDA’s home page 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.
A cow was found containing tissue residue violations reported by USDA/FSIS: Case No. 16-0107-KS, Sample No. 101299797, Ear Tags: White (b)(4), Back Tags: (b)(4), House Tag: (b)(4), Retain Tag: (b)(4), where violative levels of Penicillin and Flunixin were found in sampled tissue. Tissue sampled from this beef cow, on 02/03/2016, by the USDA/FSIS, detected violative drug residues of Penicillin 17.471 ppm Kidney (Tolerance .05 ppm) and Flunixin 0.235 ppm Liver (Tolerance 0.125 ppm).
FDA has established tolerance levels for Penicillin and Flunixin in edible tissues of cattle which are codified in Title 21, Code of Federal Regulations (C.F.R.), 556.510 and 556.286. The presence of these drugs 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 treatment records or segregate treated animals. 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 Eric Mueller, Compliance Officer, U.S. Food and Drug Administration, 10918 John Galt Blvd., Omaha, NE 68137. If you have any questions about this letter, please contact Compliance Officer Mueller at 402-331-8536 extension 101 or firstname.lastname@example.org
Cheryl A. Bigham
Kansas City District Office
Public Service Administrator
Kansas Department of Agriculture
1320 Research Park Drive
Manhattan, KS 66502