FDA WARNING_LETTER - VL Livestock Company, Inc. - July 31, 2008

On July 30-31, 2008, an FDA inspection of Mr. Van Lith's cattle feed lot in Parma, Idaho, confirmed the sale of an adulterated steer for slaughter. On June 3, 2008, a steer (Ear Tag Number [(b)(4)]) sold to [(b)(4)] Idaho, tested by USDA/FSIS, showed 8.23 ppm of sulfamethazine in liver tissue, exceeding the 0.10 ppm tolerance (21 CFR § 556.670). This violates sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(2)(C)(ii) and § 342(a)(4)].

The inspection also revealed a lack of an adequate system to ensure proper drug withdrawal times before slaughter. Deficiencies included incomplete treatment records, failure to systematically review records for withdrawal compliance, and an inadequate drug inventory system. These conditions render the food adulterated under section 402(a)(4) of the Act.

Mr. Van Lith must take prompt action to correct these violations and establish procedures to prevent recurrence. A written response detailing corrective actions and timelines is required within fifteen working days of receiving the letter. Failure to