Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm627401.htm
Timestamp: 2019-01-19 03:54:16
Document Index: 388116365

Matched Legal Cases: ['§ 342', '§ 360', '§ 342', '§ 556', '§ 342', '§ 342']

Welter Farms Inc 11/27/18
Office of Human and Animal Food-West
CMS # 562966
Nicholas S. Welter, Owner
Randy Welter, Owner
Dan Welter, Owner
16836 Hannan Road
Holy Cross, Iowa 52053-9762
Dear Messrs. Welter:
On July 17-18, and 20, 2018, the U.S. Food and Drug Administration (FDA) conducted an investigation of your beef cattle operation located at 16836 Hannan Road, Holy Cross, Iowa. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov.
We found that you offered an animal for sale as food that was adulterated. Under section 402(a)(2)(C)(ii) of the FD&C 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 FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C 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 March 29, 2018, you delivered a beef steer, identified with red ear tag #32 and back tag #42DE4216, for slaughter as food. On or about March 30, 2018, Long Prairie Packing Co., Long Prairie, Minnesota, 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 sulfamethazine at 0.756 parts per million (ppm) in the liver, and 0.533 ppm in the muscle. FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.670 (21 C.F.R. § 556.670). The presence of this drug in edible tissues from this animal above the tolerance causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C 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. You failed to maintain treatment records or identify treated animals. Specifically, your firm does not maintain any physical or written records for your beef cattle, including treatment records for injured or sick cattle. You also fail to maintain records regarding the identity, purchase, or sale of your cattle. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).
Your written response should be sent to Danial S. Hutchison, Compliance Officer, U.S. Food and Drug Administration, 8050 Marshall Drive – Suite 205, Lenexa, Kansas 66214. If you have any questions about this letter, please contact Compliance Officer Hutchison at 913-495-5154 or danial.hutchison@fda.hhs.gov.
cc: Mr. Randy Watts, Bureau Chief
Wallace State Building
randy.watts@iowaagriculture.gov