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WARNING LETTER
•Karcz Nation LLC•April 2, 2026

Karcz Nation LLC – FDA Warning Letter, Apr 2, 2026

Record Details

Following an inspection from March 30 to April 2, 2026, the FDA issued a warning letter to Karcz Nation, LLC, a dairy farm in Pulaski, Wisconsin. The agency discovered significant violations of the Federal Food, Drug, and Cosmetic Act involving the sale of animals for food that contained illegal levels of drug residues. Specifically, testing revealed concentrations of ampicillin and ceftiofur markers in cow tissues that exceeded safety limits set by the FDA and USDA. The farm was cited for failing to follow drug labeling instructions, a practice known as extralabel use, without the required supervision of a licensed veterinarian. Issues included administering excessive dosages, failing to observe mandatory withdrawal periods before selling animals for slaughter, and using medications to treat conditions not approved on the labels. Furthermore, the farm"s misuse of cephalosporins—antimicrobials critical for human health—is strictly prohibited under federal regulations due to the risk of antibiotic resistance. The FDA also noted that the farm"s treatment records were incomplete, lacking vital details like dosage amounts, administration dates, and withdrawal schedules. Although the co-owners submitted preliminary corrective plans, the FDA determined these actions were insufficient to address all identified concerns. The company is required to submit a detailed written response within 15 working days outlining specific, documented steps taken to improve record-keeping, ensure proper drug administration, and prevent future occurrences of harmful residues in the food supply.

Company
Karcz Nation LLC
Inspection date
April 2, 2026
Product type
veterinary
Office
Center for Veterinary Medicine
People
  • Jacob J. Karcz
  • Dillon J. Karcz
View Company Profile

ID · f91121f7-8675-40f2-9fb6-3f88b1f0879c

Violation Codes10
21 CFR 556.40(b)(1)21 CFR 556.113(b)(1)(i)FD&C Act 402(a)(2)(C)(ii)21 U.S.C. 342(a)(2)(C)(ii)FD&C Act 512(a)(4)(B)21 U.S.C. 360b(a)(4)(B)FD&C Act 301(a)21 U.S.C. 331FD&C Act 402(a)(4)21 CFR 21 U.S.C. 342(a)(4)

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