FDA WARNING_LETTER - Simoes & Sons Dairy, Inc. - June 29, 2011

On June 16 and 29, 2011, the FDA inspected Simoes & Sons Dairy, Inc. in Elk Grove, California, and found violations of the Federal Food, Drug, and Cosmetic Act. The dairy adulterated new animal drugs, specifically chlortetracycline and sulfamethazine in (b)(4) (Type B - Medicated Feed), (b)(4) (neomycin sulfate) Oral Solution, and (b)(4) (flunixin meglumine) Injectable Solution, by using them extralabelly.

The extralabel use of these drugs was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a). This caused the drugs to be unsafe under section 512(a) and adulterated under section 501(a)(5) of the FD&C Act. Additionally, the animal feed (b)(4) (Type B - Medicated Feed) was adulterated under section 501(a)(6) because it was not used in conformance with its approved labeling, making it unsafe under section 512. Extralabel use of medicated feeds is not permitted by 21 C.F.R. 530.11(b).

Simoes & Sons Dairy must take prompt action to correct these violations and establish procedures to prevent recurrence. Failure to