- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Animal & Veterinary
Recipient NameMr. Patrick S. Knobbe
- Knobbe Cattle Company Inc.
1037 C Road
West Point, NE 68788
- Issuing Office:
- Division of Human and Animal Food Operations West II
May 31, 2023
Reference: CMS case 657009
Dear Mr. Patrick Knobbe:
An inspection of your custom-feeding cattle feedlot operation Knobbe Cattle Company Inc. located at 1037 C Road, West Point, Nebraska, was conducted by a representative of the U.S. Food and Drug Administration (FDA) on March 15 and March 17, 2023. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that we found during our inspection 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.
At the close of the inspection, you were issued a Form FDA 483, Inspectional Observations (FDA 483). We acknowledge your email response to the Division on March 31, 2023. You stated your employee failed to review treatment records before loading the cow for shipment. This employee was reprimanded and retrained by your veterinarian on the proper protocol. FDA will verify the corrective actions during a future inspection.
Adulteration of an Animal Offered for Human Consumption
Our inspection found you offered for sale an animal for slaughter as food that was adulterated. Specifically, on or about September 8, 2022, you sold a beef cow identified with a (b)(4) and (b)(4) for slaughter as food. The animal was slaughtered on or about September 8, 2022, at (b)(4). The United States Department of Agriculture/Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from the animal identified the presence of (b)(4) at (b)(4) parts per million (ppm) in the kidney tissue. FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur, a metabolite breakdown of ceftiofur class drugs, in the kidney tissues of cattle in Title 21, Code of Federal Regulations, 556.113(b)(1)(i) (21 CFR 556.113(b)(1)(i)).
The presence of this drug in edible tissue from this animal at this level causes the food to be adulterated. A food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe.1 A drug is unsafe if it results in any residues that exceed any established safe levels.2 The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act.3
Additionally, our inspection found that you hold animals under conditions that are inadequate such that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. Specifically, you failed to implement your procedures of reviewing treatment records prior to shipping the cow with pink ear tag (b)(4) and (b)(4) for slaughter when your employee did not review the treatment records. The failure to follow your protocols and review treatment records resulted in this cow being sold for slaughter before the proper meat withdrawal time indicated on the drug label. Food held under conditions whereby it may have been rendered injurious to health is adulterated.4
Adulteration of a New Animal Drug
Our inspection found you did not use EXCEDE® (Ceftiofur Crystalline Free Acid, NADA #141-209) as directed by its approved labeling. Use of a drug in a manner that is not consistent with its labeling is an extralabel use.5
Our investigation found that you administered EXCEDE® to a cow with (b)(4) failing to follow the labeled withdrawal time of (b)(4) days as stated in its approved labeling. Your extralabel use of EXCEDE® was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a) and resulted in an illegal drug residue in violation of 21 CFR 530.11(d).
Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 CFR Part 530, you caused the drug to be unsafe and adulterated.6 The introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act.7
This letter is not intended to be an all-inclusive statement of violations that may exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your firm complies with all requirements of federal law and FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to legal or regulatory action, including without limitation, seizure, and injunction.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen (15) working days, state the reason for the delay and the time frame within which you will complete the correction. If you believe you have complied with the FD&C Act and FDA regulations, include your reasoning and any supporting information for our consideration.
Please send your firm’s response 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 firstname.lastname@example.org.
LaTonya M. Mitchell, Ph.D.
Program Division Director
Office of Human and Animal Foods – West Division 2
1 See section 402(a)(2)(C)(ii) of the FD&C Act [21 U.S.C. § 342(a)(2)(C)(ii)]
2 See section 512(a)(4)(B) of the FD&C Act [21 U.S.C. § 360b(a)(4)(B)]
3 See section 301(a) of the FD&C Act [21 U.S.C § 331(a)]
4 See section 402(a)(4) of the FD&C Act [21 U.S.C. § 342(a)(4)]
5 See 21 CFR 530.3(a).
6 Under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)], a new animal drug is deemed adulterated if it is unsafe within the meaning of section 512 of the FD&C Act [21 U.S.C. § 360b].
7 See section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]