FDA WARNING_LETTER - Neely Livestock - August 13, 2014

On August 5, 12, and 13, 2014, the FDA investigated Neely Livestock, owned by Johnny K. Neely, in Murfreesboro, Tennessee. The investigation found violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, a pig sold for slaughter on April 15, 2014, was found to have penicillin and spectinomycin residues in its tissues. Penicillin was present at 0.0 ppm, exceeding the 0.0 ppm tolerance (21 CFR 556.510(b)), and spectinomycin, for which no tolerance is established (21 CFR 556.600), was also present. This rendered the food adulterated under Section 402(a)(2)(C)(ii) of the Act.

The operation also lacked an adequate system to ensure medicated animals were withheld from slaughter for appropriate withdrawal periods and failed to maintain complete treatment records, leading to adulteration under Section 402(a)(4) of the Act due to insanitary conditions.

Furthermore, the new animal drugs (b)(4) (penicillin G procaine injectable suspension, NADA 065-505) and (b)(4) (Lincomycin-Spectinomycin soluble powder, ANADA 200-380) were used in an extra-label manner without