Correia Dairy – FDA Warning Letter, Nov 2, 2012

On October 30-31 and November 2, 2012, the FDA inspected Correia Dairy in Petaluma, California, and found violations of the Federal Food, Drug, and Cosmetic Act. The dairy adulterated new animal drugs by using them extralabelly, meaning not as directed by their approved labeling, which is only permissible under specific conditions including a valid veterinarian/client/patient relationship.

Specifically, Correia Dairy administered (b)(4) (sulfadimethoxine) Injection-(b)(4) to lactating dairy cattle without following approved labeling for indications, dosage, and route, which is prohibited for extralabel use in lactating dairy cattle per 21 C.F.R. 530.41(a)(9). They also administered (b)(4) (flunixin meglumine) Injectable Solution, (b)(4) to heifer calves without following the veterinarian's prescription for animal class, and this extralabel use was not under licensed veterinarian supervision, violating 21 C.F.R. 530.11(a). Similarly, (b)(4) (oxytocic principle) Injection, (b)(4) was administered to dairy cows without following the veterinarian's prescribed dosage, also without licensed veterinarian supervision, violating 21 C.F.R. 530.11(a).

These extralabel uses, not