FDA WARNING_LETTER - Jack Hall Farm - February 13, 2014

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On February 11-13, 2014, the FDA inspected Jack Hall Farm, a dairy operation in Grayson, Kentucky, and found violations of the Federal Food, Drug, and Cosmetic Act. The farm sold a cow for slaughter on June 26, 2013, which USDA/FSIS analysis on June 27, 2013, found to contain 0.55 ppm of desfuroylceftiofur in the kidney, exceeding the 0.4 ppm tolerance (21 C.F.R. 556.113(b)(3)(i)), and 0.162 ppm of penicillin in the kidney, exceeding the 0.05 ppm tolerance (21 C.F.R. 556.510(a)). This caused the food to be adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also revealed insanitary conditions, including a failure to maintain complete treatment records, making food adulterated under section 402(a)(4). Furthermore, the new animal drug Excenel RTU (ceftiofur hydrochloride sterile suspension, NADA140-890) was adulterated due to extralabel use. The farm administered Excenel RTU to a dairy cow without following indications or withdrawal times, and without

Company: Jack Hall Farm
Inspection Date: February 13, 2014
Product Type: Drugs
Office: Cincinnati District Office
Person: Paul J. Teitell (District Director)

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ID · 891c787a-b711-4d82-b1ce-3b6c3791fcae

Violation Codes10

21 U.S.C. 342(a)(2)(C)(ii)21 U.S.C. 360b21 U.S.C. 342(a)(4)21 CFR 556.113(b)(3)(i)21 CFR 556.510(a)21 CFR 530.3(a)21 U.S.C. 360b(a)(4)21 U.S.C. 360b(a)(5)21 CFR 530.11(a)21 CFR 530.11(d)

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