FDA WARNING_LETTER - Sinan Dairy Farm - May 29, 2013

On May 22, 24, and 29, 2013, the FDA investigated Sinan Dairy Farm, identifying violations of the Federal Food, Drug, and Cosmetic Act. The farm offered for sale adulterated animals for slaughter.

Specifically, a dairy cow sold on April 3, 2013, and slaughtered on April 4, 2013, contained tilmicosin at (b)(4) ppm in the liver (tolerance 1.2 ppm) and detected sulfadoxene in the kidney (no established tolerance). Additionally, a bob veal calf sold on January 2, 2013, and slaughtered on January 3, 2013, had gentamicin in the kidney (no established tolerance). These drug residues caused the food to be adulterated under 21 U.S.C. 342(a)(2)(C)(ii).

The investigation also found insanitary conditions, including a failure to maintain treatment records, leading to adulteration under 21 U.S.C. 342(a)(4). Furthermore, the new animal drug Micotil 300 (tilmicosin) Injection was adulterated under 21 U.S.C. 351(a)(5) because it was used extralabelly without following the veterinarian's prescribed withdrawal period and without licensed veterinarian supervision, violating