| Public Health Service Food and Drug Administration |
| Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 Telephone: (612) 758-7194 FAX: (612) 334-4142 |
Department of Health and Human Services
June 15, 2010
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 10 - 16
John L. Skogen
Owner
N4688 110th Street
Elmwood, Wisconsin 54740
Dear Mr. Skogen:
On February 2, 10, and 18, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at N4688 110th Street, Elmwood, 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 September 8, 2009, you sold a dairy cow, identified with ear tag number (b)(4) and back tag number (b)(4), for slaughter as food. On or about September 9, 2009, (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 gentamicin in kidney tissue. FDA has not established a tolerance for residues of gentamicin in the edible tissues of cattle. The presence of this drug in edible tissue from this animal 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, and you are not maintaining drug inventory 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 drugs gentamicin sulfate solution, sulfadimethoxine injection, flunixin meglumine, penicillin G procaine injectable suspension, oxytetracycline hydrochloride injection, and penicillin G benzathine and penicillin G procaine injectable suspension. Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling. Use of these drugs in this manner is extralabel use per Title 21, Code of Federal Regulations (CFR), section 530.3(a) (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 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 gentamicin sulfate solution to treat replacement heifers without following the animal class as stated in the approved labeling. Your extralabel use of gentamicin sulfate solution was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11 (a), and resulted in an illegal drug residue, in violation of 21 CFR 530.11 (c).
Our investigation found that you administered sulfadimethoxine injection to lactating dairy cattle without following the conditions of use as stated in the approved labeling. Sulfadimethoxine injection is prohibited for extralabel use in lactating dairy cattle by 21 CFR 530.41 (a)(9).
Our investigation found that you administered flunixin meglumine to lactating cows without following the route of administration as stated in the approved labeling. Your extralabel use of flunixin meglumine was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11 (a).
Our investigation found that you administered penicillin G procaine injectable suspension to dairy cows without following the dosage and duration of treatment as stated in the approved labeling. Your extralabel use of penicillin G procaine injectable suspension was not under the supervision of a licensed veterinarian in violation of 21 CFR 530.11(a).
Our investigation found that you administered oxytetracycline hydrochloride injection to lactating dairy cows without following the route of administration or animal class in the approved labeling. Your extralabel use of oxytetracycline hydrochloride injection for treating hairy warts was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11 (a).
Our investigation found that you administered penicillin G benzathine and penicillin G procaine injectable suspension to dry dairy cows and heifers without following the animal class as stated in the approved labeling. Your extralabel use of penicillin G benzathine and penicillin G procaine injectable suspension 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 530, you caused the drugs to be unsafe under section 512(a) of the Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 50 1(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 fifteen (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 fifteen (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 Timothy G. Philips, Compliance Officer, at U.S. Food and Drug Administration, Minneapolis District Office, 250 Marquette Avenue, Suite 600, Minneapolis, Minnesota 55401. If you have any questions about this letter, please contact Compliance Officer Philips at (612)758-7133.
Sincerely,
/S/
Howard E. Manresa
Acting Director
Minneapolis District
xc: Robert Ehlenfeldt, DVM
State Veterinarian
WDA, Division of Animal Health
P.O. Box 8911
Madison, WI 53708-8911
Dennis Schuh
Administrator, Division of Enforcement
Wisconsin Department of Regulation & License
P.O. Box 8935
Madison, WI 53708-8935
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