Sullivan Lane Farm – FDA Warning Letter, Jan 12, 2012

On January 5 and 12, 2012, the FDA investigated Sullivan Lane Farm, a dairy farm operation. The investigation revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on or about October 24, 2011, the farm sold a dairy cow for slaughter that was found to be adulterated. USDA/FSIS analysis of tissue samples from this animal, slaughtered on October 25, 2011, identified 0.288 ppm Sulfamethazine residue in the liver. FDA has not established a tolerance for Sulfamethazine in dairy cows, rendering the food adulterated under section 402(a)(2)(C)(ii) of the Act.

Additionally, the investigation found that animals were held under insanitary conditions, specifically due to a failure 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 within fifteen working days, including steps taken to correct violations and prevent recurrence. Failure to comply may result in regulatory action such as seizure or injunction. The FDA may also assess fees for re-inspection-related costs due to the identified noncompliance related to food safety.