Inspections, Compliance, Enforcement, and Criminal Investigations

Sachau, Jake 2/18/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Kansas City District
8050 Marshall Drive
Suite 205
Lenexa. Kansas 66214-1524
913-495-5100 

WARNING LETTER

CMS # 489288

February 18, 2016
 
UPS
RETURN RECEIPT REQUESTED
 
Mr. Jakob D. Sachau, Owner
2441 I Avenue
Denison, IA  51442
 
Dear Mr. Sachau:
 
On December 17-18 and 21, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your cow/calf operation located at 2441 I Avenue, Denison, IA 51442. 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. 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 October 3, 2015, you sold a cow, identified with back tag number (b)(4) for slaughter as food. On or about October 5, 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 1.857 ppm of Tilmicosin in the liver. FDA has established a tolerance of 1.2 ppm for residues of Tilmicosin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.735 (21 C.F.R. § 556.735). 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 so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain treatment records or segregate treated animals. 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 sent to Danial S. Hutchison, Compliance Officer, U.S. Food and Drug Administration, 8050 Marshall Drive, Suite 205, Lenexa, KS 66214. If you have any questions about this letter, please contact Compliance Officer Hutchison at 913-495-5154 or danial.hutchison@fda.hhs.gov.
 
Sincerely yours,
/S/
Cheryl A. Bigham
District Director
Kansas City, District
 
cc:
Randy Watts
Commercial Feed and Fertilizer Bureau Chief
502 E 9lh Street
Des Moines, IA 50319

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