FDA WARNING_LETTER - Roorda Dairy, LLC - April 23, 2018

On July 9, 2018, the FDA issued a Warning Letter to Roorda Dairy, LLC, following an investigation on April 17 and 23, 2018. The investigation found that Roorda Dairy offered for sale an adulterated animal for slaughter. Specifically, a cow sold on January 2, 2018, with ear tag (b)(4), was found to have tetracycline residues of 65.05 ppm in kidney tissue and 6.73 ppm in muscle tissue, exceeding the FDA tolerances of 12 ppm and 2 ppm respectively, violating 21 U.S.C. § 342(a)(2)(C)(ii).

The investigation also revealed the extralabel use of Vetrimycin® 100 (oxytetracycline hydrochloride). The drug, labeled for intravenous use, was administered as an intrauterine infusion, an extralabel use not authorized by a licensed veterinarian, violating 21 C.F.R. § 530.11(a) and (d). This rendered the drug unsafe and adulterated under 21 U.S.C. § 360b(a) and 21 U.S.C. § 351(a)(5).

Furthermore, Roorda Dairy provided a false Livestock Owner Certificate on July 11, 2013, stating