FDA WARNING_LETTER - Stephen A. Langmaid - February 02, 2012

On January 27 and February 2, 2012, the FDA inspected Stephen A. Langmaid's dairy cattle grower operation in Sulphur Springs, Texas. The inspection found violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on October 6, 2011, a calf sold for slaughter was found to be adulterated. USDA/FSIS analysis of tissue samples from this animal, slaughtered on October 7, 2011, revealed tulathromycin in kidney tissue and sulfamethazine at 0.273 ppm in liver tissue and 0.154 ppm in muscle tissue. While tulathromycin has a tolerance of 5.5 ppm in cattle, this tolerance does not apply to calves processed for veal, and there is no acceptable residue level for tulathromycin in veal calves. Sulfamethazine exceeded its 0.1 ppm tolerance. These drug levels caused the food to be adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

Additionally, the operation held animals under insanitary conditions, failing to maintain treatment records, which could lead to medicated animals with harmful residues entering the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4).

The FDA requires prompt corrective action, including implementing systems for animal identification, traceability, determining prior