FDA WARNING_LETTER - Machado Dairy Farms Dairy #2 - January 14, 2013

On January 9, 11, and 14, 2013, the FDA investigated Machado Dairy Farms #2 in Stockton, California, and found violations of the Federal Food, Drug, and Cosmetic Act. The dairy adulterated new animal drugs (b)(4) (flunixin meglumine), (b)(4) (ceftiofur (b)(4)), and (b)(4) (ceftiofur (b)(4)) by using them extralabelly without following prescription or approved labeling directions.

Specifically, the investigation revealed that (b)(4) was administered to dairy cows without adhering to the servicing veterinarian's prescribed dosage and route, violating 21 C.F.R. 530.11(a) by not being under licensed veterinarian supervision. Furthermore, (b)(4) and (b)(4) were administered without following the servicing veterinarian's prescribed dosage, and their extralabel use in cattle is prohibited by 21 C.F.R. 530.41(a)(13).

These non-conforming drug uses caused the drugs to be unsafe under section 512(a) and adulterated under section 501(a)(5) of the FD&C Act. The FDA requires prompt corrective action within fifteen working days, including a written response detailing steps taken to correct violations and prevent recurrence. Failure to comply may