| 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 |
Department of Health and Human Services
May 9, 2011
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 11 – 24
Wayne C. Saemrow
Owner/Partner
Saemrow Dairy
22490 Lake Avenue
Waterville, Minnesota 56096
Dear Mr. Saemrow:
An investigation of your dairy operation located at Waterville, Minnesota, was conducted by an investigator from the Minnesota Department of Agriculture, acting on behalf of the Food and Drug Administration (FDA), on January 6, 2011. This investigation confirmed that you offered animals for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) and 402(a)(4), 21 U.S.C. §§ 342(a)(2)(C)(ii) and 342(a)(4), of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and its associated regulations on the Internet through links on the FDA web page at www.fda.gov.
On September 17, 2010, you consigned a dairy cow for slaughter as food through (b)(4). The United States Department of Agriculture Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 9.87 ppm Neomycin in kidney tissue.
A tolerance of 7.2 ppm has been established for residues of Neomycin in kidney tissues of cattle as codified in Title 21, Code of Federal Regulations (21 CFR), 556.430(b)(1). The presence of this drug in kidney tissue of 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).
The investigation also found that you hold animals under conditions that fail to prevent medicated animals bearing potentially harmful drug residues from entering the food supply. For example, you failed to maintain 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).
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 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, 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 Rebecca Caulfield, Compliance Officer, at the address indicated on the letterhead. If you have any questions about this letter, please contact Ms. Caulfield at (612) 758-7194.
Sincerely,
/S/
Gerald J. Berg
Director
Minneapolis District
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