Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Atlanta District Office|
60 8th St., NE
Atlanta, GA 30309
April 2, 2015
James H. Cabaniss, Jr., Co-Owner
Jonathan D. Cabaniss, Co-Owner
2007 Union Point Rd.
Stephens, GA 30667
An investigation of your dairy operation located at 448 Sunset Drive, Maxeys, GA 30671, was conducted by a representative of the U.S. Food & Drug Administration (FDA) on February 23 thru 26, 2015, confirmed that you offered animals for sale for slaughter as food that were adulterated under sections 402(a)(2)(C)(ii) (21 United States Code (U.S.C.) §342(a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. §342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). You can fmd the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.
On or about September 15, 2014, you sold two dairy cows, identified with ear tag (b)(4) back tag (b)(4) and ear tag (b)(4) back tag (b)(4) for slaughter as food. On or about September 16, 2014, (b)(4) slaughtered these animals. United States Department of Agriculture Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from these animals identified the presence of 9.71 parts per million (ppm) and 4.12 ppm desfuroylceftiofur (marker residue for Ceftiofur) respectively in kidney tissue. A tolerance level of 0.4 ppm has been established for residues of desfuroylceftiofur in the uncooked edible kidney tissue of cattle as codified in Title 21, Code of Federal Regulations, Part 556.113 (21 CFR 556.113). The presence of this drug in edible tissue from these animals causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [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. Additionally, you failed to withhold animals from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissues. Food from animals held under such conditions is considered 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 above violations and to establish procedures whereby such 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 fame 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 Janice L. King, Compliance Officer, U.S. Food and Drug Administration, 60 Eighth Street, NE, Atlanta, GA 30309. If you have any questions about this letter, please contact Compliance Officer King at 843-746-1116 or Janice.email@example.com.
Ingrid A. Zambrana
cc: Jonathan D. Cabaniss, Co-Owner
Cabaniss Dairy, LLC
448 Sunset Drive
Maxeys, GA 30671