16509 Range Line Road Cleveland, WI53015-1201 United States
Minneapolis District Office
Office of Human and Animal Foods - West Division 1
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
March 26, 2018
Via UPS Overnight Delivery Refer to CMS 547616
James L. Schmidt
16509 Range Line Road
Cleveland, Wisconsin 53015-1201
Dear Mr. Schmidt:
On January 10, January 16, and February 1, 2018, the United States Food and Drug Administration (FDA) conducted an inspection of your facility located at 16509 Range Line Road, Cleveland, Wisconsin. This letter notifies you of violations of the Federal Food, Drug, and Cosmetic Act (the Act) that were revealed during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on the 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 October 3, 2017, you sold a cow with ear tag (b)(4) and back tag (b)(4) for slaughter as food. On or about October 3, 2017, (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 desfuroylceftiofur (marker residue for ceftiofur) at 1.137 parts per million (ppm) in kidney tissue and the presence of flunixin at 0.293 ppm in liver tissue. FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur in uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (21 CFR), 556.113(b)(3)(i). FDA has established a tolerance of 0.125 ppm for residues of flunixin in uncooked edible tissues of cattle as codified in 21 CFR 556.286(b)(i). The presence of these drugs in edible tissue from this animal in these amounts 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 comply 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.
We note that during our investigation you admitted that you occasionally administer (b)(4) (flunixin meglumine) to your dairy cows without following the approved route of administration. Specifically, you admitted to treating cows with (b)(4) (flunixin meglumine) via an intramuscular injection. Flunixin meglumine is not approved for intramuscular injection. Extralabel use of this drug, if not under the supervision of a licensed veterinarian, may cause additional drug residues and is a violation of sections 512(a)(4) and (5) of the Act, 21 U.S.C. §§ 360b(a)(4) and (5), and 21 CFR Part 530.
We further note that during our investigation treatment records were not available for review. As documented in the previous FDA inspection on April 25, 2014, you were issued a form FDA 483 for records that did not include the condition treated, dosage, route of administration, the person who administered treatment, nor withdrawal times. Complete records should include this information, as well as diagnosis and indications for use.
Within 15 working days of receiving this letter you should notify this office in writing of the steps you have taken to bring your firm into compliance with the law. 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 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 Boun M. Xiong, Compliance Officer, at the address in the letterhead. If you have any questions about this letter, please contact Mr. Xiong at (414) 326-3976.
Michael Dutcher, DVM
Director, West Division 1
Office of Human and Animal Food Operations