FDA WARNING_LETTER - Gerratt Dairy - September 17, 2014

On September 15-17, 2014, the FDA inspected a dairy operation at 1350 South 2250 East, Hazelton, Idaho. The inspection revealed multiple violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

A dairy cow sold for slaughter on February 18, 2014, contained 0.17 ppm of ampicillin in kidney tissue, exceeding the 0.01 ppm tolerance (21 C.F.R. 556.40), rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act. The operation also failed to maintain complete treatment records, leading to insanitary conditions where medicated animals with harmful residues could enter the food supply, thus adulterating food under section 402(a)(4) of the FD&C Act.

Furthermore, the operation adulterated new animal drugs Polyflex, Di-Methox, Tetroxy-LA, and Excede by using them extralabelly without veterinary supervision, violating 21 C.F.R. 530.11(a). Specific violations included: Polyflex administered at an incorrect dose, resulting in illegal residues (21 C.F.R. 530.11(d)); Di-Methox used extralabelly in lact