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WARNING LETTER
•Jerland Farm•January 25, 2013

Jerland Farm – FDA Warning Letter, Jan 25, 2013

Record Details

On January 17 and 25, 2013, the FDA inspected Jerland Farms, a dairy operation in Barron, Wisconsin. The inspection revealed multiple violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on October 3, 2012, Jerland Farms sold a dairy cow for slaughter that was found to be adulterated. USDA/FSIS analysis of tissue samples from this animal, slaughtered on October 3, 2013, showed 1.1 ppm of desfuroylceftiofur residue in the kidney and 0.303 ppm of flunixin in the liver. These levels exceed the FDA tolerances of 0.4 ppm for desfuroylceftiofur in kidney and 0.125 ppm for flunixin in liver, rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also found that Jerland Farms held animals under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, thus adulterating food under section 402(a)(4) of the FD&C Act. An example cited was the failure to maintain complete treatment records.

Furthermore, Jerland Farms adulterated new animal drugs, specifically (b)(4) (ceftiofur sodium) Sterile Powder and (b)(4) (fl

Company
Jerland Farm
Inspection date
January 25, 2013
Product type
Drugs
Office
Minneapolis District Office
People
  • Michael Dutcher (Acting Assistant Commissioner)
  • Michael F. Johnson
  • Steven Ingham
View Company Profile

ID · be6e7357-6fbd-41c5-9c90-a4883441b9d7

Violation Codes10
21 U.S.C. 342(a)(2)(C)(ii)21 U.S.C. 360b21 U.S.C. 342(a)(4)21 CFR 556.11321 CFR 556.28621 CFR 530.3(a)21 U.S.C. 360b(a)(4)21 U.S.C. 360b(a)(5)21 CFR 53021 CFR 530.11(a)

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