FDA WARNING_LETTER - Ontario Ranch Holsteins - December 06, 2013

On November 5 and December 6, 2013, the FDA investigated Ontario Ranch Holsteins, identifying multiple violations of the Federal Food, Drug, and Cosmetic Act. A dairy cow sold for slaughter on July 19, 2013, contained desfuroylceftiofur at 0.5 ppm in kidney tissue, exceeding the 0.4 ppm tolerance (21 C.F.R. 556.113(b)(3)(i)), rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The operation also held animals under insanitary conditions, failing to maintain treatment records, which could lead to medicated animals with harmful drug residues entering the food supply, thus adulterating food under section 402(a)(4). Furthermore, the new animal drug Excenel RTU was adulterated (section 501(a)(5)) due to extralabel use not conforming to approved labeling and not under veterinarian supervision, violating 21 C.F.R. 530.11(a) and resulting in illegal residues (21 C.F.R. 530.11(d)).

Additionally, a false guaranty was provided on July 19, 2013, stating animals presented for slaughter did not have illegal drug residues, which is prohibited