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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Norm-E-Lane, Inc. 21-Feb-06

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

Public Health Service
Food and Drug Administration

 

Minneapolis District Office
Central Region
212 Third Avenue South
Minneapolis, MN 55401
Telephone: (612) 758-7132
FAX: (612) 334-4142



February 21, 2006

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Refer to MIN 06-21

Jerry N. Meissner
President
Norm-E-Lane, Inc.
W136 Panther Creek Road
Chili, WI 54420

Dear Mr. Meissner:

An investigation of your dairy operation located at W276 Panther Creek Road, Chili, WI, conducted by a representative of the U .S. Food and Drug Administration (FDA) on December 23, 2005, and January 3, 2006, confirmed that you offered an animal for sale for slaughter as food that was adulterated under Sections 402(a)(2)(C)(ii) [21 U.S.C. 342(a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). The inspection also revealed that you caused the new animal drugs sulfadimethoxine and penicillin G procaine to become adulterated within the meaning of Section 501(a)(5) [21 U.S.C. 351(a)(5)] and unsafe under Section 512 of the Act [21 U.S.C. 360b]. You can find the Act and its associated regulations on the Internet through links on the FDA's web page
at www.fda.gov.

On or about November 10, 2005, you consigned a dairy cow, identified with back tag 0289, for slaughter as food through [redacted]. On or about November 11, 2005, this animal was slaughtered at [redacted] United States Department of Agriculture Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 2.06 ppm sulfadimethoxine in liver tissue, and 0.61 ppm penicillin in kidney tissue. A tolerance of 0.1 ppm has been established for residues of sulfadimethoxine in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations, 556.640 (21 CFR 556.640) . A tolerance of 0.05 ppm has been established for residues of penicillin in the edible tissues of cattle (21 CFR 556.5 10). The presence of these drugs in excess of the tolerances set forth in 21 CFR 556.640 and 21 CFR 556.510 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. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you lack an adequate monitoring system to ensure that medications are administered to the designated animal. 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)].

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 above violations and to establish procedures whereby such 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, 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 Brian D. Garthwaite, Ph.D., Compliance Officer, at the address in the letterhead. If you have any questions about this letter, please contact Dr. Garthwaite at 612-758-7132.

Sincerely,

/S/

W. Charlcs Bccoat
Director
Minneapolis District