Inspections, Compliance, Enforcement, and Criminal Investigations

Lorch Farms Inc 10/6/16

  

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 # 508213
 
October 6, 2016
 
UPS
RETURN RECEIPT REQUESTED
 
Mr. Daniel Lorch, Partne/Co-Owner
Lorch Farms, Inc.
2176 100th Avenue
Harris, Iowa 51345
 
Dear Mr. Lorch:
 
An investigation of your cattle feeding operation located at Harris, IA, confirmed that you offered an animal for sale for slaughter as food which was adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. 342 (a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. 342 (a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and its associated regulations on the Internet through links on the FDA’s web page at www.fda.gov.  This investigation was conducted on September 14-15, 2016, by Iowa Department of Agriculture and Land Stewardship (IDALS) while representing the U.S. Food and Drug Administration (FDA).  
 
On or about June 27, 2016, you shipped a steer, identified with an orange #(b)(4) tag, for slaughter for human food to (b)(4).  On or about June 28, 2016 this animal was slaughtered at the (b)(4) slaughtering facility. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 3.47 ppm of desfuroylceftiofur (the marker residue for Ceftiofur) in the kidney tissue of the animal. A tolerance of 0.4 ppm has been established for residues of Ceftiofur in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Part 556.# (21C.F.R. 556.113). The presence of this drug in edible tissue from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [(21 U.S.C. § 342(a)(2)(C)(ii)].
 
Our investigation also found that you hold cattle under conditions that are so inadequate that medicated cattle bearing potentially harmful drug residues are likely to enter the food supply. You lack an adequate system to ensure the cattle medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you failed to maintain treatment records for your cattle, you failed to properly segregate treated animals and you failed to verify treatment of cattle before shipping. 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 Tamara Umscheid, 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 Umscheid at 913-495-5128 or Tamara.Umscheid@fda.hhs.gov.
 
Sincerely yours,
/S/ 
Cheryl A. Bigham
District Director
Kansas City, District
 
 
cc:   
Randy Watts
Iowa Department of Agriculture and Land Stewardship (IDALS)
Wallace Building       
502 E. 9th Street                     
Des Moines, IA 50319
           
David Lorch, President
2176 100th Avenue
Harris, Iowa 51345

 

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