FDA WARNING_LETTER - Vander Schaaf Dairy #2 - September 27, 2010

On January 10, 2011, the FDA issued a Warning Letter to Vander Schaaf Dairy #2 following an investigation on September 22 and 27, 2010. The investigation found the dairy offered an adulterated animal for slaughter and held animals under insanitary conditions.

Specifically, a dairy cow sold on April 9, 2010, and slaughtered on April 10, 2010, had sulfadimethoxine in its liver tissue at 7.068 ppm, exceeding the 0.1 ppm tolerance, rendering the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii). The dairy also failed to maintain complete treatment records, leading to adulterated food under 21 U.S.C. 342(a)(4).

Furthermore, the dairy adulterated new animal drugs by using sulfadimethoxine, penicillin G procaine, and ceftiofur extralabel without veterinary supervision, violating 21 C.F.R. Part 530. Extralabel use of sulfadimethoxine is prohibited in lactating dairy cows (21 C.F.R. 530.41(a)(9)), and its extralabel use resulted in illegal residues (21 C.F.R. 530.11(d)). Specific