FDA WARNING_LETTER - Byron Kramer, Inc. - July 08, 2015

On July 6-8, 2015, the FDA inspected Byron Kramer, Inc.'s cow/calf operation in Holyoke, Colorado, and found violations of the Federal Food, Drug, and Cosmetic Act. A steer sold for slaughter on April 8, 2015, was found to have adulterated tissue. USDA/FSIS analysis revealed florfenicol at 6.52 ppm in liver and 2.07 ppm in muscle, exceeding FDA tolerances of 3.7 ppm and 0.3 ppm, respectively. Sulfamethazine was also found at 10.12 ppm in liver, exceeding the 0.1 ppm tolerance. These levels caused the food to be adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also revealed insanitary conditions, specifically a failure to maintain complete treatment records and medication inventory, leading to adulterated food under section 402(a)(4). Furthermore, the new animal drug (b)(4) was adulterated under section 501(a)(5) because it was used extralabelly without following the withdrawal time and without the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a) and (d).

Byron Kramer, Inc. must take prompt action to correct these violations and prevent recurrence. The