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  5. Derrek Olson, LLC - 509792 - 12/15/2016
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WARNING LETTER

Derrek Olson, LLC MARCS-CMS 509792 —

Product:
Animal & Veterinary

Recipient:
Derrek Olson, LLC


United States

Issuing Office:
Minneapolis District Office

United States


 

   

Black HHS-Blue FDA Logo

 

 

 
Minneapolis District
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401 334-4100
(612) 334-4100

 

December 15, 2016
 
 
WARNING LETTER
 
 
Via UPS Overnight Delivery                                                        Refer to MIN 17 – 04
           
 
Derrek R. Olson
Owner
Derrek Olson, LLC
26896 570th Street
Plainview, Minnesota  55964-4588
 
Dear Mr. Olson:
 
On September 29 and October 3, 2016, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 26896 570th Street, Plainview, Minnesota. 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 February 11, 2016, you sold a dairy cow that was subsequently identified with the back tag #(b)(4) for slaughter as food. On or about February 12, 2016, (b)(4), slaughtered this animal. U.S. Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of flunixin at 0.632 parts per million (ppm) in the liver tissue. FDA has established a tolerance of 0.125 ppm for residues of flunixin in the liver (target tissue) of cattle as codified in Title 21, Code of Federal Regulations, section 556.286 (21 CFR 556.286). The presence of this drug in edible tissues 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 document the dosage amount, route of administration, condition being treated, frequency of administration, and the dates for meat/milk withdrawal times. 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).
 
We also found that you adulterated the new animal drug, (b)(4) (flunixin meglumine injectable solution, 50 mg/mL, ANADA #(b)(4)). Specifically, our investigation revealed that you did not use this drug as directed by its approved labeling and/or by the veterinarian’s prescription because you did not follow the withdrawal time on the label prior to offering the animal for slaughter. Use of this drug in this manner is an extralabel use. See 21 CFR 530.3(a).
 
The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the Act, 21 U.S.C. §§ 360b(a)(4) and (5), and 21 CFR 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) (flunixin meglumine injectable solution, 50 mg/mL, ANADA #(b)(4)) to a dairy cow identified with the back tag #(b)(4) and failed to follow the approved meat withdrawal time frames as stated on the approved labeling. Your extralabel use of (b)(4) (flunixin meglumine injectable solution, 50 mg/mL, ANADA #(b)(4)) was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a), and the extralabel use resulted in illegal drug residues, in violation of 21 CFR 530.11(d). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 CFR Part 530, you caused the drug to be unsafe under section 512(a) of the Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the 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 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 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 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 Dr. Brian D. Garthwaite, Compliance Officer, U.S. Food and Drug Administration, 250 Marquette Avenue, Suite 600, Minneapolis, Minnesota 55401. If you have any questions about this letter, please contact Dr. Garthwaite at (612) 758-7132.
 
Sincerely,
/S/
Michael Dutcher, DVM
Director
Minneapolis District

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