FDA WARNING_LETTER - Old Carolina Farms - November 27, 2007

An FDA inspection of Old Carolina Farms, located at 10802 Cook Brothers Road, Ijamsville, Maryland, conducted from October 16, 2007, to November 27, 2007, revealed multiple violations. A bob veal calf offered for slaughter on July 25, 2007, and slaughtered on July 26, 2007, contained sulfamethazine residues of 131.89 ppm in liver tissue and 179.88 ppm in muscle tissue, significantly exceeding the 0.1 ppm tolerance (21 CFR 556.670). This rendered the food adulterated under sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

The operation lacked an adequate system to ensure appropriate drug withdrawal periods, failing to maintain treatment records, leading to adulterated food under section 402(a)(4) of the Act. Furthermore, a false guaranty was provided on April 9, 2001, stating no livestock would have illegal drug residues, which was violated on July 25, 2007, a prohibited act under section 301(h) of the Act.

The new animal drug sulfamethazine was also adulterated under section 50