FDA WARNING_LETTER - Ferreira and Son Dairy - March 14, 2012

On March 14, 2012, the FDA inspected Ferreira and Son Dairy in Red Bluff, California, and found violations of the Federal Food, Drug, and Cosmetic Act. The dairy adulterated the new animal drug (b)(4) (flunixin meglumine injectable solution), (b)(4), by using it in an extralabel manner, which is only permissible under specific conditions outlined in 21 C.F.R. Part 530.

Specifically, the dairy administered (b)(4) to a bob veal calf without following the animal class and indications for use prescribed by their veterinarian and approved labeling. Additionally, they administered the drug to dairy cows without adhering to the prescribed route of administration. These extralabel uses were not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a). Consequently, the drug was rendered unsafe under section 512(a) and adulterated under section 501(a)(5) of the FD&C Act.

Ferreira and Son Dairy must take prompt action to correct these violations and implement procedures to prevent recurrence. Failure to comply may lead to regulatory actions like seizure or injunction. A written response detailing corrective actions and timelines is required within fifteen working days to the FDA's San Francisco District office.