- Animal & Veterinary
- Conrad Shada
- Issuing Office:
- Kansas City District Office
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
December 4, 2015
Ref. CMS #484337
Via United Postal Service
405 Old Dubuque Rd.
Anamosa, IA 52205
Dear Mr. Shada:
On November 2-4, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your cattle operation located at 405 Old Dubuque Rd., Anamosa, IA 52205. 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.
Specifically, our investigation revealed that on or about July 31, 2015, you offered a steer, identified with a yellow (b)(4) ear tag, later tagged with back tag # (b)(4) for slaughter as food. On or about August 4, 2015, (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 florfenicol at 5.73 parts per million (ppm) in the liver tissue and florfen.icol at 0.36 ppm in the muscle tissue. FDA has established a tolerance of 3.7 ppm for residues of florfenicol in liver tissue of cattle and 0.3 ppm in muscle tissue of cattle as codified in Title 21, Code of federal Regulations (C.F.R.), 283(b)(1)(i) and (ii) (21 C.F.R. 556.283(b)(1)(i) and (ii)). 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).
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 Jessica E. Hensley, Compliance Officer, U.S. Food and Drug Administration, 8050 Marshall Dr., Suite 205, Lenexa, KS 66214. If you have any questions about this letter, please contact Compliance Officer Hensley at 913-495-5183 or Jessica.email@example.com.
Cheryl A. Bigham
Kansas City District