Brad D. Smith Farm – FDA Warning Letter, Oct 21, 2019

On October 10 and 21, 2019, the FDA inspected Brad D. Smith Farm, a cattle farm in Estherville, IA. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act.

A cow sold for slaughter on May 28, 2019, was found to be adulterated. Tissue samples from the animal, slaughtered on May 31, 2019, showed Florfenicol at 0.33 ppm in muscle tissue, exceeding the 0.3 ppm tolerance (21 CFR § 556.283). Additionally, (b)(4) was detected in kidney tissue, for which no tolerance exists. These findings render the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The farm also lacked an adequate system to ensure medicated animals were withheld from slaughter for appropriate withdrawal periods, leading to potential drug residues in the food supply. This includes discarding discharge instructions with withdrawal periods and failing to maintain complete treatment records (condition, dosage, route, administrator, withdrawal times). This constitutes adulteration under section 402(a)(4) of the FD&C Act.

Furthermore, the new animal drug (b)(4) and human drug (b)(4) were adulterated due to extra-label use not complying with 21 CFR Part 53