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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Farmers Coop Co 8/16/12

  

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

Public Health Service
Food and Drug Administration
 
Kansas City District
Southwest Region
11630 West 80th Street
Lenexa, Kansas 66214-3340
 
Telephone:    (913) 752-2100 

 

                                                                                                                                                                  
August 16, 2012
 
 
CERTIFIED MAIL 
RETURN RECEIPT REQUESTED
 
WARNING LETTER
Ref. – KAN 2012-13
 
Mr. Steven Recker, President
Farmers Cooperative Company
105 Main St
PO Box 45 
Hospers, IA 51238-0045
 
 
Dear Mr. Recker:
 
On March 29 and 30, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your medicated feed mill located at 105 Main Street, Hospers, 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
 
Our investigation found that your feed mill failed to use SAFE-GUARD 0.5% [fenbendazole] Type B medicated feed in conformance with its labeling and the approved uses for fenbendazole.  Fenbendazole is not approved for use in animal feed for sheep/lambs, and SAFE-GUARD 0.5% is labeled for use only in swine, beef, dairy, and horse.  However, you used SAFE-GUARD 0.5% Type B medicated feed to manufacture Type C medicated feed for use in sheep/lambs.  Your use of SAFE-GUARD 0.5% Type B medicated feed to manufacture finished medicated feed for sheep/lambs caused the medicated feed to be unsafe under section 512(a)(2)(A)(i) [21 U.S.C. § 360b(a)(2)(A)(i)] and adulterated under section 501(a)(6) [21 U.S.C. § 351(a)(6)] of the FD&C Act.
 
In addition, our investigation found that you failed to provide labels to accompany the bulk medicated feed you distribute to your customers.  Your failure to label the bulk medicated feed you distribute is a significant deviation from the Current Good Manufacturing Practice (CGMP) regulations applicable to facilities manufacturing medicated feeds for which a license is not required, Tile 21 Code of Federal Regulations sections 225.120 through 225.202 (21 C.F.R. §§ 225.120 – 225.202).  Specifically, 21 C.F.R. § 225.180 requires all deliveries of medicated feeds, whether bagged or in bulk, to be adequately labeled to assure the feed can be properly used.  Your deviation from CGMP regulations causes the medicated feeds manufactured at your facility to be adulterated within the meaning of section 501(a)(2)(B) [21 U.S.C. § 351(a)(2)(B)] of the FD&C Act. 
 
The above is not intended to be an all-inclusive list of violations. As a manufacturer of medicated feed, you are responsible for ensuring that your overall operation and the medicated feed you distribute are 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, 11630 W 80th Street, Lenexa Kansas 66214. If you have any questions about this letter, please contact Compliance Officer Hutchison at 913-752-2774.
 
Sincerely,
/S/
John Thorsky
District Director
Kansas City District
 
Cc: Steve Moline, Bureau Chief
       IDALS
       Wallace State Office Building
       502 E. 9th Street
       Des Moines, IA 50319