Da Silva Dairy – FDA Warning Letter, Apr 19, 2011

On April 7, 18, and 19, 2011, the FDA investigated Da Silva Dairy, identifying multiple violations of the Federal Food, Drug, and Cosmetic Act. A bob veal calf sold for slaughter on November 3, 2010, was found to have unsafe levels of gentamicin in kidney tissue, rendering the food adulterated under section 402(a)(2)(C)(ii). The dairy also failed to maintain complete treatment records, leading to insanitary conditions where medicated animals with harmful drug residues could enter the food supply, adulterating food under section 402(a)(4).

Furthermore, the dairy possessed prescription new animal drugs (Ceftiofur, Oxytocin Injection, Dexamethasone Solution) without valid veterinary prescriptions, violating sections 512(a)(4) and (5) and rendering the drugs unsafe and adulterated under section 501(a)(5). The dairy also engaged in extralabel use of Ceftiofur, Dexamethasone Solution, and Penicillin G Procaine Injectable Suspension without veterinary supervision, violating 21 C.F.R. 530.11(a) and causing these drugs to be unsafe and adulterated.

Da Silva Dairy must take prompt action to correct these violations and establish procedures to prevent recurrence. A written response detailing corrective actions and timelines is required within fifteen working days to Darlene Alm