Lakeview Dairy, LLC - 565303 - 10/19/2018

October 19, 2018

WARNING LETTER

Via UPS Overnight Delivery Refer to CMS 565303

Michael D. Roecker, Co-Owner
Bruce G. Walker, Co-Owner
Lakeview Dairy, LLC
N8783 Basswood Road
Beaver Dam, Wisconsin 53916-9352

Dear Messrs. Roecker and Walker:

Between June 7 - 28, 2018, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at W8998 Laurel Hill Road, Fox Lake, 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 the 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 February 2, 2018, you sold a dairy cow with back tag number (b)(4) for slaughter as food (your farm ear tag number (b)(4)). On or about February 2, 2018, (b)(4), slaughtered this animal. The U.S. Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of desfuroylceftiofur (marker residue for ceftiofur) at 1.508 parts per million (ppm) in the kidney tissue. FDA has established a tolerance of 0.4 ppm for residues of ceftiofur in the uncooked edible tissue of cattle as stated in Title 21, Code of Federal Regulations (CFR), 556.113 (21 CFR 556.113). 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. Your records did not include the amount of drug administered, the site of administration, milk/meat withhold times, and the name of the person who administered the drug. 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 (b)(4) (ceftiofur hydrochloride, NADA (b)(4)). Specifically, our investigation revealed that you did not use this drug as directed by its approved labeling or veterinary prescription. The use of this drug, in this manner, is 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.

Specifically, you administered (b)(4) to the dairy cow identified with back tag number (b)(4) (your farm ear tag number (b)(4)), without following the directions for use as stated in the approved labeling or the veterinary prescription. You admitted to administering (b)(4) for a duration of nine days rather than the five-day period directed in the approved labeling. Your treatment records indicate that you routinely administer (b)(4) for longer than the five-day period directed in the approved labeling. You also admitted to administering a final dose of (b)(4) on January 30, 2018, and shipping this animal on February 1, 2018, sooner than the end of the four-day meat withhold period directed in the approved labeling. Your extralabel use of (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a), and your extralabel use of this drug resulted in an illegal drug residue, in violation of 21 CFR 530.11(c). Ceftiofur hydrochloride is prohibited for extralabel use in food-producing animals by 21 CFR 530.41(a)(13)(ii).

Because your use of this drug was not in conformance with the 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 comply 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.

To date, we have not received a response to the Form FDA-483 issued on June 28, 2018.

Your written response should be sent to Dianna C. Sonnenburg, Compliance Officer, at the address in the letterhead. If you have any questions about this letter, please contact Ms. Sonnenburg at (612) 758-7125.

Sincerely,
/S/
Michael Dutcher, DVM
Director, West Division 1
Office of Human and Animal Food Operations