| Public Health Service Food and Drug Administration |
Minneapolis District Office |
Department of Health and Human ServicesJuly 8, 2011
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 11 - 37
Leo M. Veeser
Owner
Veeser Farms
E2566 River Road
Casco, Wisconsin 54205
Dear Mr. Veeser:
On January 27 and February 16, 2011, the Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at E2566 River Road, Casco, Wisconsin. 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 October 6, 2010, you sold a bob veal calf, identified with back tag # (b)(4) , for slaughter as food. On or about October 6, 2010, (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 24.35 parts per million (ppm) of neomycin residue in the kidney. FDA has established a tolerance of 7.2 ppm for residues of neomycin in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations, section 556.430 (21 CFR 556.430). However, this tolerance does not apply to the use of (b)(4) Neomycin Oral Solution Antibacterial (ANADA (b)(4) in calves to be processed for veal (preruminating calves), and there is no acceptable level of residue associated with the use of this drug in veal calves. The presence of this drug in edible tissue 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 maintain complete treatment records. 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 neomycin sulfate (Neomycin Oral Solution Antibacterial), ANADA #(b)(4). Specifically, our investigation revealed that you did not use neomycin sulfate as directed by its approved labeling. 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 neomycin sulfate in a class of animal (veal calf with back tag #(b)(4)) not set forth in the approved labeling and you did so without following the extralabel use directions of a licensed veterinarian, in violation of 21 CFR 530.11(a). Furthermore, your extralabel use of neomycin sulfate resulted in an illegal residue, in violation of 21 CFR 530.11(c). 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, 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/
Gerald J. Berg
Director
Minneapolis District
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