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  5. Kevin Klug - 588725 - 08/28/2019
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WARNING LETTER

Kevin Klug MARCS-CMS 588725 —


Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Animal & Veterinary
Food & Beverages

Recipient:
Recipient Name
Kevin Klug
Recipient Title
Owner
Kevin Klug

56628 893rd Rd
Wynot, NE 68792-3009
United States

Issuing Office:
Office of Human and Animal Food-West Division II

8050 Marshall Drive - Suite 205 Lenexa, Kansas
66214-1524
United States


WARNING LETTER

Reference: CMS case# 588725

Dear Mr. Kevin J. Klug:

On June 10, 2019, and July 3, 2019, the Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 56628 893rd Rd., Wynot, Nebraska. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA's web page at www.fda.gov.

Adulterated Food

We found you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the FD&C 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 FD&C Act, 21 U.S.C. §360b.

Specifically, our investigation revealed that on January 3, 2019, you sold a cow identified with an ear tag number (b)(4) for slaughter as food. On January 4, 2019, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of a tissue sample collected from this animal identified the presence of Desfuroylceftiofur at 1.216 parts per million (ppm) in the kidney tissue.

FDA has established for the new animal drug, (b)(4) (Ceftiofur Crystalline Free Acid, NADA #(b)(4)) a tolerance of 0.4 ppm for residues of Desfuroylceftiofur (marker residue) in the kidney tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), section 556.113(b)(3)(i) (21 C.F.R. § 556.113(b)(3)(i)). The presence of this drug in edible tissue from this animal in amounts above the tolerance causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).

Adulterated Animal Drugs
We also found that you adulterated the new animal drug (b)(4) (Ceftiofur Crystalline Free Acid, NADA #(b)(4)). Specifically, our investigation revealed you did not use (b)(4) as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See 21 C.F.R § 530.3(a).

The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. §§ 360b(a)(4) and (5), and FDA regulations in 21 CFR Part 530. Among other things, these require that the use be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. In addition, some drugs may not be used in an extralabel manner even on the order of a veterinarian; they are listed in 21 CFR 530.41.

Specifically, you administered (b)(4) (Ceftiofur Crystalline Free Acid, NADA# (b)(4) to the dairy cow identified with ear tag number (b)(4) without following the directions for use as stated in the approved labeling or the veterinary prescription. You stated that you treated this dairy cow with one dose of (b)(4) on December 13, 2018, and another dose on December 20, 2018, rather than administering the second dose 72 hours after the initial dose as directed in the approved labeling. You calculated the dose of (b)(4) based on an estimated weight of 1200 pounds, whereas the actual weight of the animal was 850 pounds, which overdosed the cow. You also state that you routinely administer (b)(4) on the side of the tailhead, which is not an approved route of administration, instead of subcutaneous injection in the posterior aspect of the ear as directed in (b)(4) 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). Furthermore, Ceftiofur Crystalline Free Acid is a Cephalosporin antibiotic, which is prohibited from extralabel use in food-producing animals by 21 C.F.R. 530.41(a)(13)(ii).

Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C 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 your overall operation and the food you distribute is in compliance with the law.

You should take prompt action to correct the violations described in this letter and to establish procedures to ensure these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.

During our investigation we did not assess the adequacy of your treatment records for the dairy cow identified with ear tag number (b)(4) because you reported that you kept them in the previous year's calendar which you had since discarded. We note that in discussion with our investigator you committed to keeping your records for a minimum of a year in the future.

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 have 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 Kara L. Roden, Compliance Officer, U.S. Food and Drug Administration, 8050 Marshall Dr., Suite 205, Lenexa, KS 66214. If you have any questions about this letter, please contact Compliance Officer Roden at (913) 495-5121, or by email at kara.roden@fda.hhs.gov.

Sincerely yours,
/S/
Cheryl Bigham
Program Division Director
Office of Human and Animal Food, West Division II