- Animal & Veterinary
- Potthast Farm
- Issuing Office:
- Chicago District Office
Chicago District Office
550 W. Jackson Blvd., 15th Floor
Chicago, lL 60661
Telephone: (312) 353-5863
Fax: (312) 596-4187
December 5, 2016
VIA UPS NEXT DAY
Gerald R. Potthast, Partner
Eugene Potthast, Partner
14260 Waffler Rd.
Aviston, IL 62216
Dear Messrs. Gerald and Eugene Potthast:
On October 18, 2016 through October 19, 2016, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 14260 Waffler Rd., Aviston, IL. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that were 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 investigation revealed that on or about July 28, 2016, you sold cow, identified with back tag (b)(4) and ear tag (b)(4) for slaughter as food. On or about July 29, 2016, (b)(4), slaughtered this animal. The 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 at a level of 1.367 ppm. FDA has established a tolerance of 0.4 ppm for residues of Desfuroylceftiofur in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556. 113 (b)(3)(i) (21 C.F.R. 556.113 (b)(3)(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 inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain 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).
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 addressed to:
Lauren Crivellone, Compliance Officer
FDA Chicago District Office
U.S. Food and Drug Administration
550 W. Jackson Blvd., Suite 1500
Chicago, IL 60661
Refer to the Unique Identification Number (CMS Case # 510160) when replying. If you have any questions about this letter, please contact Compliance Officer Lauren Crivellone via email at Lauren.Crivellone@fda.hhs.gov
or by phone at (312) 596-4157.
William R. Weissinger
Gerald Kirbach, Bureau Chief
Illinois Department of Agriculture
Paul Wolseley, District Manager
United States Department of Agriculture
Food Safety and Inspection Service