FDA WARNING_LETTER - Syracuse Dairy LLP - April 28, 2011

On April 19-21 and April 28, 2011, the FDA inspected Syracuse Dairy LLP in Syracuse, Kansas, and found violations of the Federal Food, Drug, and Cosmetic Act. The primary violation was offering for sale an adulterated animal for slaughter. Specifically, on November 29, 2010, a dairy cow (ear tag (b)(4)) sold by Syracuse Dairy LLP was slaughtered, and USDA/FSIS analysis revealed flunixin residues of 0.383 ppm in liver tissue and 0.0489 ppm in muscle tissue. These levels exceed the FDA tolerances of 0.125 ppm for liver and 0.025 ppm for muscle, as codified in 21 C.F.R. § 556.286, rendering the food adulterated under section 402(a)(2)(C)(ii) of the Act [21 U.S.C. § 342(a)(2)(C)(ii)]. Syracuse Dairy LLP is responsible for ensuring compliance and must take prompt action to correct these violations and prevent recurrence. Failure to comply may result in regulatory actions like seizure or injunction. A written response detailing corrective actions and prevention procedures is required within fifteen working days of receiving the letter.