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  5. Valley Mead Farms LLC - 12/18/2014
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WARNING LETTER

Valley Mead Farms LLC Dec 18, 2014

Valley Mead Farms LLC - 12/18/2014

Product:
Animal & Veterinary

Recipient:
Valley Mead Farms LLC


United States

Issuing Office:
Minneapolis District Office

United States


   

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

 

December 18, 2014
 
 
WARNING LETTER
 
 
via UPS Overnight Delivery                                           
Refer to MIN 15 – 04
 
 
Duane A. Bernet
Owner
Valley Mead Farms, LLC
N6395 County Road N
Monticello, Wisconsin 53570-9795
 
Dear Mr. Bernet:
 
On April 28 and May 12, 2014, the United States Food and Drug Administration (FDA), conducted an investigation of your dairy operation located at N6395 County Road N, Monticello, Wisconsin. 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.
 
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 December 2, 2013, you sold a dairy cow identified with back tag (b)(4) and farm bangle tag (b)(4) for slaughter as food. On or about December 3, 2013, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of edible tissue from that cow identified the presence of 1.14 parts per million (ppm) of residues of sulfadimethoxine in liver tissue, 0.763 ppm of residues of sulfadimethoxine in muscle tissue, and 0.656 ppm of residues of flunixin in liver tissue. FDA has established a tolerance of 0.1 ppm sulfadimethoxine in uncooked, edible tissues of cattle, as codified in Title 21, Code of Federal Regulations, section 556.640(b)(1), 21 CFR 556.640(b)(1), and a tolerance of 0.125 ppm flunixin in uncooked edible liver tissue of cattle, as codified in 21 CFR 556.286(b)(1)(i).  The presence of these drugs in these 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 complete treatment records that included correct meat and milk withhold times, dose administered, route of administration, and responsible person. 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 (b)(4) (sulfadimethoxine injection 40%, ANADA (b)(4)), (b)(4) (sulfadimethoxine) bolus, NADA (b)(4)), (b)(4) (flunixin meglumine injectable solution, ANADA (b)(4)), and (b)(4) (sterile penicillin G procaine injectable suspension, NADA (b)(4)). Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling or veterinary prescription. The use of these drugs in this manner is an extralabel use as defined in 21 CFR 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 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) (sulfadimethoxine Injection 40%) to a dairy cow identified with back tag (b)(4) and farm bangle tag (b)(4) without following the dose as stated in the approved label.  Your extralabel use of sulfadimethoxine was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a) and your extralabel use of sulfadimethoxine resulted in an illegal drug residue in violation of 21 CFR 530.11(d). Sulfonamide drugs, which include sulfadimethoxine, are prohibited for extralabel use in lactating dairy cattle as defined in 21 CFR 530.41(a)(9).
 
Our investigation found that you administered (b)(4) (sulfadimethoxine) to a dairy cow identified with back tag (b)(4) and farm bangle tag (b)(4) without following the dose as stated in the approved label.  Your extralabel use of sulfadimethoxine was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a) and your extralabel use of sulfadimethoxine resulted in an illegal drug residue in violation of 21 CFR 530.11(d). Sulfonamide drugs, which include sulfadimethoxine, are prohibited for extralabel use in lactating dairy cattle as defined in 21 CFR 530.41(a)(9).
 
Our investigation found that you administered (b)(4) brand flunixin meglumine to a dairy cow identified with back tag (b)(4) and farm bangle tag (b)(4) without following the route of administration as stated in the approved label. Your extralabel use of flunixin was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a) and your extralabel use of flunixin resulted in an illegal drug residue in violation of 21 CFR 530.11(d). 
 
Our investigation found that you adulterated (b)(4) brand penicillin G procaine by not following the dose as stated in the approved label.  Your extralabel use of penicillin was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a).
 
Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 CFR Part 530, you caused the 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 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.
 
We received Ms. Keppen’s May 22, 2014, letter responding to the FDA 483, Inspectional Observations, issued at the close of the inspection on May 12, 2014. Ms. Keppen stated in the response that you have made adjustments on proper dosages and better “weight” evaluations to avoid over-dosing animals, but the response did not include documents supporting these corrective actions. 
 
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, Food and Drug Administration, at the address located on the letterhead. 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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