TH Mello and Sons Dairy – FDA Warning Letter, Oct 2, 2012

On September 25, 26, and October 2, 2012, the FDA investigated TH Mello and Sons Dairy in Galt, California, and found violations of the Federal Food, Drug, and Cosmetic Act. The dairy adulterated new animal drugs, specifically Sulfadimethoxine Soluble Powder and Flunixin Meglumine Injectable Solution, by using them extralabelly without adhering to approved labeling or regulatory requirements.

The investigation revealed Sulfadimethoxine Soluble Powder was administered to a lactating dairy cow, which is prohibited for extralabel use in such animals per 21 C.F.R. 530.41(a)(9). Additionally, Flunixin Meglumine Injectable Solution was administered to lactating dairy cows without following dosage and conditions for use, and crucially, without the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a). These extralabel uses caused the drugs to be unsafe under section 512(a) and adulterated under section 501(a)(5) of the FD&C Act.

TH Mello and Sons Dairy must take prompt action to correct these violations and establish procedures to prevent recurrence. Failure to comply may result in regulatory action, including seizure and/or injunction. A written response detailing corrective actions and timelines is required within fifteen working days of receiving the letter, to be