Inspections, Compliance, Enforcement, and Criminal Investigations

Frontier Cooperative Co 3/9/16

  

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

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

 

March 9, 2016
 
Warning Letter
CMS#482837
 
VIA UPS OVERNIGHT DELIVERY
 
Randy Robeson, President/General Manager
Frontier Cooperative Company
211 South Lincoln,
PO Box 37
Brainard, NE 68626
 
 
Dear Mr. Robeson:
 
Inspectors from The Food and Drug Administration (FDA) and the Nebraska Department of Agriculture (NDA) conducted an inspection on September 22-28, 2015 of your licensed medicated feed mill, located at 2175 14th Ave, Columbus, NE 68601. This inspection was initiated due to a potential Class I recall of a medicated goat feed with Monensin by your firm. During this inspection, samples were collected.  The inspection and samples revealed significant violations of the Federal Food, Drug, and Cosmetic Act (the Act).  Such violations caused the animal food and drug distributed by your firm to be adulterated. You can find the Federal Food, Drug, and Cosmetic Act and its implementing regulations through links on FDA's web page at http://www.fda.gov.
 
Your medicated animal food (b)(4) Goat Feed Pellet, containing the new animal drug Monensin, is unsafe under section 512(a)(2)(A) of the Act, [21 U.S.C. § 360B(a)(2)(A)] and adulterated under section 501(a)(6) of the Act, [21 U.S.C. § 351(a)(6)] because its use does not conform with the approval for the drug Monensin.  Monensin is approved for use in medicated animal food tor goats at a level of 20 grams/ton, as indicated by Title 21 Code of Federal Regulations, Part 558, [21 CFR 558.355(f)(6)]. According to our sample results, Monensin was found at 1401.34 parts per million (1,271.3 grams/ton) in your (b)(4) Goat Feed. The feeding of this super-potent medicated animal food appears to have resulted in the deaths of at least 14 goats and an additional 12 ill goats.
 
Your medicated animal food (b)(4) Goat Feed Pellet, containing the new animal drug Monensin, is also unsafe under section 512(a)(2)(A) of the Act, [21 U.S.C. § 360B(a)(2)(A)] and adulterated under section 501 (a)(6) of the Act, [21 U.S.C. § 351 (a)(6)] because its labeling does not conform to the approved representative ("bluebird") labeling for Monensin. The labeling for your (b)(4) Goat Feed Pellet medicated animal food failed to include the required caution and warning statements and feeding directions as indicated on the bluebird label. (The bluebird label is available on FDA's website at: http://www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/Medicated.Feed/BlueBirdLabels/default.htm.)
 
This inspection also documented significant deviations from the Current Good Manufacturing Practice (CGMP) regulations for licensed medicated feed manufacturers, Title 21, Code of Federal Regulations, Part 225 [21 CFR 225.10- 225.115]. The following deviations cause medicated animal food manufactured, processed, packed, or held at your facility to be adulterated under Section 501(a)(2)(B) [21 U.S.C. § 351(a)(2)(B)] of the FD&C Act.
 
1.    Your establishment failed to have adequate training and supervision to ensure the proper formulation, manufacture, and control of a medicated animal food as required by 21 CFR 225.10(a).
 
Specifically, your lack of adequate training and supervision resulted in the improperly formulated batch of medicated animal food for goats that, as discussed above, appears to have resulted in the deaths of at least 14 goats and an additional 12 ill goats. Employees manufacturing the medicated animal food and supervisors reviewing the records did not identify or comprehend that the level of Monensin added would cause the medicated animal food to become adulterated.
 
2.    Your establishment failed to provide adequate labeling to identify a medicated animal food as required by 21 C.F.R. 225.80(a).
 
Specifically the label attached to the 50 pound bags of the medicated animal food did not provide the user with directions for use to assure the article is safe and effective for its intended purposes.
 
The above is not intended to be an all-inclusive list of violations. You are responsible for assuring that your overall operation and any products you distribute comply 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 enforcement action without further notice such as seizure and/or injunction.
 
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover costs for certain activities, including re-inspection-related costs. Re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of there- inspection and assessing and collecting there-inspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
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 taken or will be taken to correct the violations and prevent their recurrence in your remaining animals. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the period 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 Dania! 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.
 
Sincerely yours,
/S/
Cheryl A. Bigham
District Director
Kansas City District

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