FDA WARNING_LETTER - God's Little Dairy - May 08, 2014

On April 29, May 1 and 8, 2014, the FDA inspected God's Little Dairy. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, a calf sold for slaughter on November 21, 2013, and slaughtered on November 22, 2013, contained cefazolin in kidney tissue, for which FDA has not established a tolerance in calves for human food. This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Furthermore, the dairy failed to maintain complete treatment records, indicating insanitary conditions where medicated animals with potentially harmful drug residues could enter the food supply, adulterating food under section 402(a)(4) of the FD&C Act.

The human drug (b)(4), USP, (b)(4), was used extralabelly on a calf without following the dose and animal class specified in the servicing veterinarian's prescription. This extralabel use was not under the supervision of a licensed veterinarian (violating 21 C.F.R. 530.11(a)) and resulted in an illegal residue (violating 21 C.F.R. 530.11(c)). Additionally, (b)(4), USP, is prohibited for extralabel use in cattle by