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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Balsiger Greiner Rohweder Dairy, LLP 26-Oct-05

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) 334-4100
FAX: (612) 334-4142



October 26, 2005

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT RETURN REQUESTED

Refer to Min 06 - 10

Fritz Balsiger
Partner/Manager
Balsiger, Greiner, Rohweder Dairy, LLP
27998 County Road 9
Lake Park, Minnesota 56554

Dear Mr. Balsiger:

An investigation of your dairy operation, conducted by representatives of the U.S. Food and Drug Administration (FDA) and the Minnesota Department of Agriculture on June 21 and 22, 2005, confirmed that you offered animals 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 drug [redacted] brand of tilmicosin 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 March 15, 2005, you sold a dairy cow, identified with back tag 2934, for slaughter as food through [redacted]. On or about March 16, 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 6 .64 ppm tilmicosin in liver tissue, and 7.20 ppm tilmicosin in muscle tissue.

On or about March 15, 2005, you sold a dairy cow, identified with back tag 2941, for slaughter as food through [redacted]. On or about March 16, 2005, this animal was slaughtered at [redacted] USDA/FSIS analysis of tissue samples collected from that animal identified the presence of 15.05 ppm tilmicosin in liver tissue, and 4.53 ppm tilmicosin in muscle tissue.

A tolerance of 1.2 ppm in liver and 0.1 ppm in muscle has been established for residues of tilmicosin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations , Part 556.735 (21 CFR 556.735). The presence of this drug in excess of the tolerance set forth in 21 CFR 556.735 in edible tissues from these animals causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [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 failed to review treatment records prior to offering an animal for slaughter for human food to assure that appropriate withdrawal times have been observed. 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)].

In addition, you adulterated tilmicosin within the meaning of section 501(a)(5) of the Act [21 U.S.C. 351(a)(5)] when you failed to use the drug in conformance with its approved labeling. "Extralabel use," i.e., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, is only permitted if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. The extralabel use of approved veterinary or human drugs must comply with sections 512(a)(4) and 512(a)(5) of the Act [21 U.S.C. 360b(a)(4), 360b(a)(5)] and 21 CFR Part 530. Our investigation found that your extralabel use of tilmicosin failed to comply with these requirements.

For example, you administered the tilmicosin without following the approved animal class set forth. in the approved labeling and you did so without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). Furthermore, your extralabel use resulted in an illegal drug residue, in violation of 21 CFR 530.11(c). Because your extralabel use of this drug was not in compliance with 21 CFR Part 530, the drug was unsafe under section 512(a) of the Act [21 U.S.C. 360b(a)] and your use caused it to be 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 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/

H. Tom Warwick for W. Charles Becoat
Director
Minneapolis District