FDA WARNING_LETTER - CLA-COR Farms LLC - October 15, 2015

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On October 13-15, 2015, the FDA inspected CLA-COR Farms, LLC, a dairy operation in Easton, Missouri, and found violations of the Federal Food, Drug, and Cosmetic Act.

The investigation revealed that on or about September 1, 2015, CLA-COR Farms sold a culled dairy cow for slaughter with ear tag #(b)(4). USDA/FSIS analysis of tissue samples from this animal identified desfuroylceftiofur (marker for ceftiofur) at 1.31 ppm in the kidney, exceeding the FDA tolerance of 0.4 ppm (21 C.F.R. 556.113(b)(3)(i)). This caused the food to be adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Additionally, the FDA found that CLA-COR Farms held animals under insanitary conditions, failing to adequately maintain and retain complete treatment records, which could lead to medicated animals with harmful drug residues entering the food supply. This constitutes adulteration under section 402(a)(4) of the FD&C Act.

The company also adulterated new animal drugs, Spectramast LC (ceftiofur hydrochloride, NADA #141-238) and Excede (ceftiofur crystalline free acid, NADA

Company: CLA-COR Farms LLC
Inspection Date: October 15, 2015
Product Type: Drugs
Office: Kansas City District Office
Person: Cheryl A. Bigham (Division Director)

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ID · b05d2343-17b4-4456-a489-446f642e2a11

Violation Codes10

FD&C Act 402(a)(2)(C)(ii)21 U.S.C. 342(a)(2)(C)(ii)FD&C Act 51221 U.S.C. 360bFD&C Act 402(a)(4)21 U.S.C. 342(a)(4)21 CFR 530.3(a)FD&C Act 512(a)(4)21 U.S.C. 360b(a)(4)FD&C Act 512(a)(5)

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