FDA WARNING_LETTER - Kirk Farris - August 25, 2015
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On August 20-25, 2015, the FDA inspected Kirk and Sandy Farris's cattle operation in Dimmitt, Texas, finding violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved the sale of an adulterated bull for slaughter on February 6, 2015. USDA/FSIS analysis of tissue samples from this animal revealed 0.084 ppm of penicillin in the kidney, exceeding the FDA tolerance of 0.05 ppm (21 C.F.R. 556.510), and the presence of ciprofloxacin, for which no tolerance has been established. This rendered the food adulterated under section 402(a)(2)(C)(ii) of the Act.
Additionally, the operation was found to hold animals under insanitary conditions, specifically failing to maintain 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 Act. The FDA requires prompt corrective action to prevent recurrence, warning of potential regulatory actions like seizure or injunction. A written response detailing corrective steps and timelines is required within fifteen working days of receiving the letter.
ID · 1f5a1120-6743-450c-8fa4-c3fa3e2a161d
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