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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Erickson Dairy LLC 3/3/14

  

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

Public Health Service
Food and Drug Administration
 
Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142 

 

March 3, 2014
 
 
WARNING LETTER
 
 
Via UPS Overnight Delivery                                 
Refer to MIN 14 – 08
 
 
James M. Erickson, Co-Owner
Agnes T. Erickson, Co-owner
Erickson Dairy, LLC
W4929 Sand Road
Neillsville, Wisconsin 54456-6566
 
Dear Mr. and Mrs. Erickson:
 
On December 2, 4, and 6, 2013, the Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at W4929 Sand Road, Neillsville, Wisconsin.  This letter notifies you of 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 for sale an animal for slaughter 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 June 13, 2013, you sold a dairy cow identified with back tag (b)(4) (farm tag (b)(4)) for slaughter as food.  On or about June 13, 2013, (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 desfuroylceftiofur (marker residue for ceftiofur) at 1.51 parts per million (ppm) in the kidney and flunixin at 1.02 ppm in the liver. 
 
FDA has established tolerances of:
 
  • 0.4 ppm for residues of desfuroylceftiofur in kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113(b)(3)(i) (21 C.F.R. 556.113(b)(3)(i));
  • 0.125 ppm for residues of flunixin in the liver tissue of cattle as codified in 21 C.F.R. 556.286(b)(1)(i). 
 
The presence of these drugs in edible tissues from this animal in these amounts 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.  For example, you failed to maintain treatment records and failed to maintain records regarding the identity of animals that you sold for transport and sale at an auction yard.  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).
 
We also found that you adulterated the new animal drugs listed below:
 
  • (b)(4) (ceftiofur hydrochloride sterile suspension, NADA (b)(4));
  • (b)(4) (flunixin meglumine injectable solution, ANADA (b)(4));
  • (b)(4) (ampicillin trihydrate sterile suspension, NADA (b)(4)).
 
Specifically, our investigation revealed that you did not use (b)(4), (b)(4) and (b)(4) as directed by their approved labeling.  Use of these drugs in this manner is an extralabel use.  See 21 C.F.R. 530.3(a).
 
The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.
 
Our investigation found that you administered (b)(4) to a dairy cow with back tag (b)(4) (farm tag (b)(4)) without following the amount of injection per site as stated in the approved labeling and veterinary prescription label.  Your extralabel use of (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of (b)(4) resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). 
 
Our investigation found that you administered (b)(4) to a dairy cow with back tag (b)(4) (farm tag (b)(4)) without following the route of administration as stated in the approved labeling.  Your extralabel use of (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of (b)(4) resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). 
 
Our investigation found that you administered (b)(4) to a dairy cow with farm tag (b)(4) without following the duration of treatment as stated in the approved labeling. Your extralabel use of (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a).
 
Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused these drugs to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5).
 
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 are in compliance with the law. 
 
You should take prompt action to correct the violations described in this letter and 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 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 15 working days of receiving this letter, state the reason for the delay and the timeframe 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 Timothy G. Philips, Compliance Officer, at the address on this letterhead.  If you have any questions about this letter, please contact Mr. Philips at (612) 758-7133.
 
                                                         
Sincerely,
/S/ 
Michael Dutcher, DVM
Director
Minneapolis District