FDA WARNING_LETTER - Lewisburg Livestock Market, Inc - January 15, 2015

On January 7 and 15, 2015, the FDA inspected Lewisburg Livestock Market, Inc. in Lewisburg, Tennessee, and found violations of the Federal Food, Drug, and Cosmetic Act. A culled Black Angus cow sold on October 11, 2014, and slaughtered on October 15, 2014, contained florfenicol residues (19.36 ppm in liver, 6.99 ppm in muscle) exceeding the FDA tolerances (3.7 ppm in liver, 0.3 ppm in muscle). Additionally, flunixin residues (4.55 ppm in liver, 0.27 ppm in muscle) exceeded tolerances (0.125 ppm in liver, 0.025 ppm in muscle). This rendered the food adulterated under Section 402(a)(2)(C)(ii) of the Act.

The facility also held animals under insanitary conditions, leading to adulterated food under Section 402(a)(4). Specifically, the firm failed to maintain treatment records and lacked a system to ensure medicated animals were withheld from slaughter for appropriate withdrawal periods. Furthermore, the firm engaged in extralabel use of flunixin meglumine (Prevail®) by administering it without following the approved route and without the lawful order of a licensed veterinarian, violating 21 CFR 530.11(a